FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD IS-1
MDR report key: 74016
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00668
- Event Type
- Malfunction
- Date Received
- January 16, 1997
- Date of Event
- November 6, 1996
- Report Date
- November 14, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING THE CAPPING OF A PATIENT'S ENTIRE LEAD SYSTEM (DUE TO A SENSING ISSUE WITH ANOTHER COMPANY'S LEADS), THEY ATTEMPTED TO IMPLANT AN ENDOTAK LEAD (0074 202720), HAD PROBLEMS WITH IMPEDANCE MEASUREMENTS, AND REMOVED THE FIRST (0074 202720), AND REPLACED IT WITH ANOTHER (0074 201178).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD IS-1 Implant | TRANSVENOUS DEFIBRILLATION LEAD | LWS | CARDIAC PACEMAKERS | 0074 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | THE DEVICE 1600/756033 WAS IMPLANTED 20-SEP-1993| THE DEVICE 0041/123919 WAS IMPLANTED 15-MAY-1990| THE DEVICE 0041/123240 WAS IMPLANTED 15-MAY-1990| THE DEVICE 6836/010473 WAS IMPLANTED 06-NOV-1996| THE DEVICE 0074/201178 WAS IMPLANTED 06-NOV-1996 |