FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK ENDURANCE RX
MDR report key: 289828
·
Received May 9, 2000
Report
- Report Number
- 2124215-2000-01677
- Event Type
- Malfunction
- Date Received
- May 9, 2000
- Date of Event
- February 16, 2000
- Report Date
- February 19, 2000
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH WAS IMPLANTED SUBPECTORALLY AND THEREFORE PART OF THE ADVISORY GROUP, WAS PROPHYLACTICALLY EXPLANTED. DURING THE EXPLANT PROCEDURE, A NEW TRANSVENOUS DEFIBRILLATION ENDURANCE RX LEAD WAS ALSO IMPLANTED; HOWEVER, THE LEAD WAS EXPLANTED A FEW DAYS AFTER THE PROCEDURE DUE TO A DISLODGMENT AND INADEQUATE PACING MEASUREMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK ENDURANCE RX | TRANSVENOUS DEFIBRILLATION LEAD | DTB | CARDIAC PACEMAKERS | 0145 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other | THE DEVICE 1783/601560 WAS IMPLANTED 01-OCT-1998 |