FDA Adverse Event
Injury
Summary report: N
SUTURELESS MYOCARDIAL UNIPOLAR LEAD
MDR report key: 120267
·
Received September 8, 1997
Report
- Report Number
- 2124215-1997-02080
- Event Type
- Injury
- Date Received
- September 8, 1997
- Date of Event
- June 3, 1997
- Report Date
- June 3, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS UNIPOLAR LEAD WAS REMOVED FROM SERVICE. THE PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THIS LEAD WAS EXPERIENCING OVERSENSING. THE LEAD AND ICD WERE REPLACED. TWO UNIPOLAR LEADS (BOTH MODEL 4312 SERIAL 043378 AND 043379) ARE INVOLVED IN THE PATIENT'S LEAD SYSTEM, CPI IS UNABLE TO DETERMINE WHICH SERIAL HAS THE PROBLEM, THEREFORE WILL REPORT ON SERIAL 043378 LEAD AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUTURELESS MYOCARDIAL UNIPOLAR LEAD Implant | UNIPOLAR LEAD | LWS | CARDIAC PACEMAKERS | 4312 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | THE DEVICE 0125/217113 WAS IMPLANTED 30-JUN-1997| THE DEVICE 0040/110761 WAS IMPLANTED 18-DEC-1990| THE DEVICE 1725/253149 WAS IMPLANTED 25-MAR-1997| THE DEVICE 4312/043379 WAS IMPLANTED 18-DEC-1990| THE DEVICE 0041/129975 WAS IMPLANTED 18-DEC-1990| THE DEVICE 1762/606315 WAS IMPLANTED 30-JUN-1997 |