FDA Adverse Event
Injury
Summary report: N
ENDOTAK DOWN-SIZED PLUS
MDR report key: 95618
·
Received May 8, 1997
Report
- Report Number
- 2124215-1997-01321
- Event Type
- Injury
- Date Received
- May 8, 1997
- Date of Event
- February 24, 1997
- Report Date
- February 24, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT CONCLUSION CPI RELIABILITY ASSURANCE TESTING OF THE DEVICE FOUND THE TOOL-LESS CONNECTOR SPRING ELECTRODES (IN BOTH THE ATRIAL AND VENTRICULAR CONNECTORS) TO HAVE NO METALLURGICAL ANOMALIES. THE DEVICE WAS PUT THROUGH A SERIES OF DIAGNOSTIC TESTS, WHICH VERIFY THE PERFORMANCE OF THE TELEMETRY, PACING, SENSING, AND DEFIBRILLATION THERAPY. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS AND WAS FOUND TO MEET ELECTRICAL SPECIFICATIONS. A TRANSVENOUS DEFIBRILLATION LEAD (MODEL 0125, SERIAL 213170) WAS ALSO EXPLANTED DURING THE REPLACEMENT PROCEDURE. RELIABILITY ASSURANCE TESTING FOUND THE LEAD TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
AND IS INVOLVED IN AN ADVISORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DOWN-SIZED PLUS Implant | TRANSVENOUS DEFIBRILLATION LEAD | LWS | CARDIAC PACEMAKERS | 0125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | THE DEVICE 1810/300034 WAS IMPLANTED 02-SEP-1996| THE DEVICE 4269/256526 WAS IMPLANTED 02-SEP-1996 |