[1980]
The patient has a history of atrioventricular block/sinus arrest with syncope. A pacemaker was initially implanted during 1970 and was replaced on several occasions, the most recent being 7/20/89. The patient presented to the hospital on 1/23/92 for pacemaker check and the unit was noted to be not sensing. The lead position was satisfactory and a "bench test done by intermedics pacing systems analyzer revealed that no sensing parameters could be telemetered. Thus, pulse generator malfunction was suspected. On 1/24/92, the pulse generator was removed and replaced under local anesthesia. The patient is doing well post-operatively. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-91. Service provided by: other. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: electrical problem, none or unknown, none or unknown, rate-modulated pacing sensing failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5