FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK DSP
MDR report key: 244165
·
Received February 10, 1999
Report
- Report Number
- 2124215-1999-00011
- Event Type
- Malfunction
- Date Received
- February 10, 1999
- Date of Event
- August 6, 1998
- Report Date
- August 6, 1998
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECIEVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE DEFIBRILLATION SYSTEM EXPERIEINCED AN INNAPPROPRIATE SHOCK IN SINUS RHYTHM. AN INVASIVE PROCEDURE WAS PERFORMED AND THE LEAD SYSTEM WAS FOUND TO BE COILED (TWIDDLERS SYNDROME). THE TRANSVENOUS DEFIBRILLATION LEAD WAS FOUND TO BE FRACTURED AND WAS EXPLANTED.(MODEL 125, SN 201620). A NEW LEAD WAS IMPLANTED (MODEL 125, SN 311035).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP Implant | TRANSVENOUS DEFIBRILLATION LEAD | LWS | CARDIAC PACEMAKERS | 0125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | THE DEVICE 0125/311035 WAS IMPLANTED 06-AUG-1998| THE DEVICE 1740/101830 WAS IMPLANTED 08-APR-1996 |