FDA Adverse Event
Injury
Summary report: N
ENDOTAK DOWN-SIZED PLUS
MDR report key: 142981
·
Received November 7, 1997
Report
- Report Number
- 2124215-1997-02668
- Event Type
- Injury
- Date Received
- November 7, 1997
- Date of Event
- August 8, 1997
- Report Date
- September 15, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A TRANSVENOUS DEFIBRILLATION LEAD WERE EXPLANTED ON AUGUST 08, 1997. THE DEVICE WAS EXPLANTED BECAUSE OF OVERSENSING. DURING THE PROCEDURE THE LEAD WAS FOUND TO HAVE DAMAGED INSULATION IN THE TERMINAL PIN AREA. THE DEVICE IS INVOLVED IN A PRODUCT 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 | NA | Required Intervention | THE DEVICE 0125/218924 WAS IMPLANTED 08-AUG-1997| THE DEVICE 1810/301159 WAS IMPLANTED 08-AUG-1997 |