FDA Adverse Event
Injury
Summary report: N
ENDOTAK DOWN-SIZED PLUS
MDR report key: 95759
·
Received May 8, 1997
Report
- Report Number
- 2124215-1997-01462
- Event Type
- Injury
- Date Received
- May 8, 1997
- Date of Event
- March 14, 1997
- Report Date
- March 13, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS ENDOTAK DOWN-SIZED PLUS LEAD (0125-211922) WAS EXPLANTED THREE WEEKS AFTER IT WAS IMPLANTED, DUE TO A LOW IMPEDANCE READING, BELOW 130 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED AND A DEFECT OF THE LEAD WAS FOUND, CAUSING A SHORT CIRCUIT. THE PHYSICIAN ELECTED TO REMOVE THE LEAD AND REPLACE IT WITH A NEW LEAD OF THE SAME MODEL.
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 | NA | Required Intervention | THE DEVICE 0125/211921 WAS IMPLANTED 12-MAR-1997| THE DEVICE 1752/500139 WAS IMPLANTED 12-FEB-1997 |