FDA Adverse Event
Injury
Summary report: N
VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MDR report key: 93970
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-00804
- Event Type
- Injury
- Date Received
- March 6, 1997
- Date of Event
- February 2, 1994
- Report Date
- October 11, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
CPI RECEIVED INFORMATION IN FEBRUARY, 1994 THAT THIS PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS FROM HIS VENTAK P IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FURTHER INVESTIGATION BY CPI FOUND THAT THE PHYSICIAN HAD FELT AT THE TIME THAT THE PROBLEMS WERE RELATED TO THE PATIENT'S CONDITION AND NOT THE ICD, AND NO FURTHER INVESTIGATION WAS CONDUCTED. ON OCTOBER 11, 1996 CPI RECEIVED FURTHER INFORMATION THAT THE PATIENT'S ICD HAD BEEN REMOVED AND REPLACED IN DECEMBER 1994 DUE TO PROBLEMS RELATED TO INAPPROPRIATE SHOCKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS | 1600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | THE DEVICE 0064/002714 WAS IMPLANTED 25-OCT-1993| THE DEVICE 0064/009179 WAS IMPLANTED 06-DEC-1994| THE DEVICE 1625/300621 WAS IMPLANTED 06-DEC-1994 |