FDA Adverse Event
Malfunction
Summary report: N
VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MDR report key: 95886
·
Received May 8, 1997
Report
- Report Number
- 2124215-1997-01589
- Event Type
- Malfunction
- Date Received
- May 8, 1997
- Date of Event
- December 17, 1996
- Report Date
- December 17, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS RETURNED TO CPI FOLLOWING EXPLANT FOR NORMAL BATTERY DEPLETION; HOWEVER, CPI ANALYSIS FOUND PREMATURE BATTERY DEPLETION. 3/12/97: THIS MDR WAS INTENDED TO BE FILED WITH THE MARCH 01, 1997 SUBMISSION, BUT WAS OVER-LOOKED BECAUSE OF A DECEMBER, 1997 YEAR LISTED IN ERROR. THE ALERT DATE SHOULD HAVE BEEN LISTED AS DECEMBER, 1996.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS | 1625 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 0040/105357 WAS IMPLANTED 02-AUG-1989| THE DEVICE 4312/027060 WAS IMPLANTED 02-AUG-1989| THE DEVICE 0041/113250 WAS IMPLANTED 02-AUG-1989| THE DEVICE 1746/601941 WAS IMPLANTED 30-OCT-1996| THE DEVICE 4312/027059 WAS IMPLANTED 02-AUG-1989 |