Conflicts of interest: science, money, and health.
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Biomedical subjects
Publications and source records attributed to Seymour Furman.
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Runaway pacemaker is an uncommon, potentially lethal circuit malfunction characterized by sudden onset of erratic pacing at rapid nonphysiological rates. Two patients with a single chamber pacemaker (Medtronic ST 8331 and 8419) presented with episodic dizziness. ECG revealed recurrent decrescendo amplitude episodes of runaway stimuli at 2,400 and 2,600 ppm, approximately 3 seconds in duration, separated by pacing at 62.5 and 65 ppm, respectively. Fortunately the runaway stimuli were subthreshold and did not result in capture of the ventricle. Emergency pulse generator replacement was uneventful. Both leads were normal and both pulse generators had low battery voltages at 1.488 and 1.78 V, respectively.
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Transvene models 6936/6966, a coaxial polyurethane ICD lead, may be prone to structural failure. These models comprise 54% of ICD lead failures in the authors' Multicenter Registry database. Because ICD leads perform a vital function, the clinical features, causes, and probability of Transvene 6936/6966 lead failure were determined. The Registry and United States Food and Drug Administration databases were queried for the clinical features and structural causes of the Transvene 6936/6966 lead failure, and a five-center substudy estimated the survival probability for 521 Transvene 6936/6966 implants. The mean time to failure was 4.8 +/- 2.1 years, and the estimated survival at 60 and 84 months after implant were 92% and 84%, respectively. Oversensing was the most common sign of failure (76%), and 24 patients experienced inappropriate shocks. The manufacturer's reports indicated that high voltage coil fracture and 80A polyurethane defects were the predominant causes of lead failure. Transvene models 6936 and 6966 coaxial polyurethane ICD leads are prone to failure over time. Patients who have these leads should be evaluated frequently. Additional studies are needed to identify safe management strategies.