FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK C
MDR report key: 253410
·
Received May 5, 1999
Report
- Report Number
- 2124215-1999-00418
- Event Type
- Malfunction
- Date Received
- May 5, 1999
- Date of Event
- February 2, 1999
- Report Date
- February 2, 1999
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS VENTAK MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A LESS THAN 10 OHM LEAD IMPEDANCE WAS MEASURED. THE ICD WAS NOT IMPLANTED. THE CHRONIC TRANSVENOUS DEFIBRILLATION LEAD, MODEL 0074 SN 003297 WAS CAPPED AND REMOVED FROM SERVICE. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C Implant | TRANSVENOUS DEFIBRILLATION LEAD | LWS | CARDIAC PACEMAKERS | 0074 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | THE DEVICE 1782/504449 WAS IMPLANTED 02-FEB-1999| THE DEVICE 0135/302517 WAS IMPLANTED 02-FEB-1999| THE DEVICE 1705/666251 WAS IMPLANTED 09-NOV-1994| THE DEVICE 1786/700399 WAS IMPLANTED 02-FEB-1999 |