[15744311]
Patient had a aicd (automatic implantable cardiac defibrillator) generator implanted on 4/21/92. Patient came to this facility due to malfunctioning of the device on 6/10/93. From a conversation with the sales representative of ventritex, it was found that the patient received inappropriate shocks from the defibrillator. The defibrillator's diagnostic electrograms showed an electrical noise consistent with a broken sensing wire. In surgery, on 6/10/93 it was found that the diag adaptor was broken. The defibrillator was functioning normally. The defibrillator and diag adaptor were removed in surgery and another was implanted with another header connector to avoid reuse of the diag adaptor. Patient did well post procedure and discharged home on 6/13/93device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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, visual examination. Results of evaluation: none or unknown. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5