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Generator Failure (generator + failure)
Selected AbstractsUnexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical OverstressPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001ROBERT G. HAUSER Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source] Practices and Outcome of Artificial Cardiac Pacing in 154 DogsJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 3 2001Mark A. Oyama Artificial pacing (AP) is a treatment for symptomatic bradyarrhythmias unresponsive to medical therapy. This retrospective study was designed to define the practices and outcome of AP in dogs at 7 referral institutions participating in the Companion Animal Pacemaker Registry and Repository (CANPACERS). The indications, implantation techniques, complications, long-term outcome, and owner satisfaction were examined. One hundred fifty-four dogs were identified as undergoing AP from January 1, 1991, to January 1, 1996. Third-degree atrioventricular (AV) block (n = 91; 59%) and sinus node dysfunction (n = 45; 29%) were the most common indications for AP. Transvenous endocardial AP systems were implanted in 136 dogs (88%), and epicardial systems were implanted in 18 (12%). Complications associated with AP were reported in 84 dogs (55%). Major complications occurred in 51 dogs (33%), including dislodgement of the pacing lead (n = 15; 10%), generator failure (n = 10; 6%), cardiac arrest during implantation (n = 9; 6%), and infection (n = 7; 5%). Minor complications occurred in 47 dogs (31%), including seroma formation (n = 18; 12%), muscle twitch (n = 17; 11%), and inconsequential arrhythmias (n = 15; 10%). Fourteen dogs (9%) experienced both major and minor complications. Survival analysis revealed 1-, 2-, and 3-year survival rates of 70, 57, and 45%, respectively. Age and presence of preexisting congestive heart failure (CHF) had a negative effect on survival (P= .001). Sixty percent of dogs with preexisting CHF died within 1 year of implantation, whereas 25% of dogs without heart failure died during the same period. Owners rated their satisfaction with the procedure as high in 80% of the dogs. [source] Vagus Nerve Stimulation for Intractable Epilepsy: Outcomes in Children and AdultsNEUROMODULATION, Issue 1 2010Won Chul Namgung MD ABSTRACT Objectives.,Vagus nerve stimulation (VNS) is an accepted treatment for medically intractable epilepsy. However, predictive factors associated with responsiveness to VNS remained unclear. We therefore sought to identify predictive factors that influence responsiveness to VNS in both children and adults. Materials and Methods.,We evaluated a retrospective series of 31 patients who underwent VNS for intractable epilepsy at Asan Medical Center from 1998 to 2006. Eighteen patients were younger than 18 years, while 13 patients were aged 18 years or older. We assessed mean seizure frequency, the number of antiepileptic drugs each patient was taking, seizure type, etiology, age at seizure onset, age at implantation, and duration of epilepsy. Results.,Forty-three percent of all patients had a seizure reduction of more than 50%. Ten (59%) children had a 50% reduction in their seizures, while three adults (23%) had such a response. Two factors were significantly different between responders and non-responders: age at implantation and age of seizure onset. In a logistic regression analysis, however, no factors were independently associated with the response to VNS. Transient hoarseness and cough were observed in eight of all patients and wound infection and generator failure in one patient each. Conclusions.,These results suggest that VNS may be a more effective treatment in children with intractable epilepsy than in adults. It remains difficult to predict which patients will respond to VNS therapy. [source] Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical OverstressPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001ROBERT G. HAUSER Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source] Feasibility and Initial Results of an Internet-Based Pacemaker and ICD Pulse Generator and Lead RegistryPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2001ROBERT HAUSER HAUSER, R., et al.: Feasibility and Initial Results of an Internet-Based Pacemaker and ICD Pulse Generator and Lead Registry. The medical community has no independent source of timely information regarding the performance of pacemaker and ICD pulse generators and leads. Accordingly, the authors established an Internet-based registry of pacemaker and ICD pulse generator and lead failures (www.pacerandicregistry.com). During the first year, they found three previously unreported device problems that were promptly communicated to the participants. Of the failures reported, 11% of ICD and 10% of pacemaker pulse generator failures were heralded by signs other than the expected elective replacement indicator (ERI). Average ICD battery longevity was 4.0 ± 0.7 years, and average dual chamber pacemaker battery longevity was 6.8 ± 2.6 years. Disrupted insulation accounted for 54% of pacemaker and 29% of ICD lead failures. Compared to pacemaker pulse generator and lead failure, ICD device failures were more likely to cause severe clinical consequences. In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures. [source] | ||||||||||