Model Number S602 |
Device Problems
Failure to Capture (1081); Defective Device (2588)
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Patient Problems
Nausea (1970); Ventricular Tachycardia (2132); Diaphoresis (2452)
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Event Date 09/29/2010 |
Event Type
malfunction
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this patient with pacemaker device has had runs of ventricular tachycardia (vt) as noted on cardiac event monitor.It was also reported that the device was not pacing.Boston scientific technical services (ts) advised that the device battery might had depleted.Patient advocate was told that the device would reach elective replacement time (ert) in two years.Also, patient advocate stated that the patient had episodes of being diaphoretic and nausea.Technical services then referred the patient to the physician.This device remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that this patient with pacemaker device has had runs of ventricular tachycardia (vt) as noted on cardiac event monitor.It was also reported that the device was not pacing.Boston scientific technical services (ts) advised that the device battery might had depleted.Patient advocate was told that the device would reach elective replacement time (ert) in two years.Also, patient advocate stated that the patient had episodes of being diaphoretic and nausea.Technical services then referred the patient to the physician.This device remains in service.No adverse patient effects were reported.Additional information indicated that the patient advocate reported non captured spikes on telemetry after colonoscopy.Technical services explained that some functions might be limited after time for replacement.Also, ts discussed device function, magnet response and expected longevity per mag rates.This device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.This supplemental report is being filed to correct adverse event or product problem date of event, initial reporter occupation (other) and all manufacturers report source.
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Search Alerts/Recalls
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