MEDTRONIC UNIPOLAR CONNECTOR
Received Jul 29, 1994 · Event occurred May 30, 1994
Report 18099 · MDR key 18099
Device
Product problems
- Failure to Capture
- Pacing Problem
Patient
61 YR
- Cardiopulmonary Arrest
Narrative
Description of Event or Problem
DUAL CHAMBER RATE RESPONSIVE PERMANENT PACEMAKER WAS INSERTED ON 5/29/94. IN THE OR, THE PACEMAKER WAS NOTED TO BE FUNCTIONING WELL BUT THE ATRIAL OUTPUT DID NOT SEEM TO CAPTURE THE ATRIUM. A CHEST X-RAY WAS OBTAINED AND CONFIRMED PROPER LEAD PLACEMENT PRIOR TO THE COMPLETION OF THE SURGERY. THE ATRIUM COULD NOT BE ACED WITH VOLTAGES UP TO 8 VOLTS, AND NO CURRENT COULD BE MEASURED. THE ATRIUM ALSO APPEARED TO BE ELECTRICALLY INSERT. 18 HOURS S/P PACEMAKER IMPLANTATION, THE PATIENT DEVELOPED BRADYCARDIA AND ARRESTED. THE ARREST WAS BELIEVED TO BE DUE TO THE PACEMAKER'S FAILURE TO CATURE. THE PATIENT RECEIVED CPR AND WAS SUCCESSFULLY RESUSCITATED. THE PACEMAKER WAS SUBSEQUENTLY INTERROGATED AND REPROGRAMMED. THE PATIENT WAS DISCHARGED HOME WITHOUT ANY LONG TERM COMPLICATIONS.