FDA Adverse Event
Malfunction
Summary report: N
SMALL PATCH LEAD A67
MDR report key: 142933
·
Received November 7, 1997
Report
- Report Number
- 2124215-1997-02620
- Event Type
- Malfunction
- Date Received
- November 7, 1997
- Date of Event
- August 12, 1997
- Report Date
- August 12, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT AT A REPLACEMENT PROCEDURE THIS SMALL PATCH LEAD WAS CAPPED. AT THE IMPLANT OF A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE DBT(DATA BASE TESTING) ELICITED A WARNING MESSAGE OF HIGH SHOCKING LEAD IMPEDANCE ON DELIVERY OF A 15J COMMANDED SHOCK. THE PHYSICIAN CHECKED THE SET SCREWS AND TRIED AGAIN WITH THE SAME RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMALL PATCH LEAD A67 Implant | SMALL PATCH LEAD | LWS | CARDIAC PACEMAKERS | 0040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | THE DEVICE 1715/210279 WAS IMPLANTED 11-MAR-1994| THE DEVICE 0040/100977 WAS IMPLANTED 07-OCT-1987| THE DEVICE 6917 WV0074 WAS USED DURING THE EVENT.| THE DEVICE 6917 WV0076 WAS USED DURING THE EVENT.| THE DEVICE 0125/220597 WAS IMPLANTED 12-AUG-1997| THE DEVICE 1746/604347 WAS IMPLANTED 12-AUG-1997| THE DEVICE 1762/606828 WAS IMPLANTED 12-AUG-1997 |