FDA Adverse Event
Malfunction
Summary report: N
VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MDR report key: 95501
·
Received May 8, 1997
Report
- Report Number
- 2124215-1997-01204
- Event Type
- Malfunction
- Date Received
- May 8, 1997
- Date of Event
- February 5, 1997
- Report Date
- March 11, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- Z462/464-2
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO CPI FOR ANALYSIS AFTER REACHING NORMAL ELECTIVE REPLACEMENT TIME (ERT). THERE WAS NO ALLEGATION RECEIVED CONCERNING THIS ICD. THIS AICD IS ON RECALL FDA# 462/464-2. THE PHYSICIAN WAS NOTIFIED 05/05/92. NOTE: THE ICD WAS REMOVED FROM SERVICE ON OCTOBER 10, 1993, AND RETURNED TO CPI FOR ANALYSIS ON JANUARY 27, 1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS | 1550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | THE DEVICE 0041/130351 WAS IMPLANTED 18-FEB-1991| THE DEVICE 0041/133907 WAS IMPLANTED 18-FEB-1991| THE DEVICE 4312/044552 WAS IMPLANTED 18-FEB-1991| THE DEVICE 4312/044551 WAS IMPLANTED 18-FEB-1991 |