FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 116891
·
Received August 29, 1997
Report
- Report Number
- 2124215-1997-09210
- Event Type
- Injury
- Date Received
- August 29, 1997
- Date of Event
- August 18, 1997
- Product Code
- LWS
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
EVENT CONCLUSION CBI RECEIVED A MEDWATCH FROM STATING: 82 Y.O. HX SUDDEN CARDIAC DEATH. PRESENTED TO UMMC WITH INCREASED SHOCKS FROM ICD. HX TRANSVENOUS ICD IMPLANTED 6/18/1993. ON EVALUATION ABNORMAL SENSING (OVERSENSING) OF THE DEVICE WAS NOTED BY BEEP-O-GRAM. PT TAKEN TO OR FOR EXTRACTION OF ENDOTAK LEAD WITH NEW SYSTEM IMPLANT. ICD WAS ALSO REPLACED DUE TO END OF LIFE STATUS. THE LEAD WAS RETURNED TO CPI, ANALYSIS FOUND: THE LEAD MEETS ELECTRICAL SPECIFICATION. VISUAL INSPECTION NOTED THE LEAD WAS SEVERED NEAR THE TERMINAL PIN, NO EVIDENCE OF AN INSULATION BREACH. THE DAMAGE APPEARS TO HAVE BEEN CAUSED DURING THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | LWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |