FDA Adverse Event
Malfunction
Summary report: N
INTERVENE LEAD
MDR report key: 383602
·
Received February 8, 2002
Report
- Report Number
- 2124215-2002-03773
- Event Type
- Malfunction
- Date Received
- February 8, 2002
- Date of Event
- October 31, 2001
- Report Date
- October 31, 2001
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT AT THE CHANGEOUT PROCEDURE OF THIS PATIENT'S ICD, A PROBLEM WAS REPORTED WITH THIS INTERVENE LEAD. TESTING REVEALED IMPEDANCE MEASUREMENTS > 3000 OHMS. INTERROGATION OF THE LEAD FOUND A FRACTURE APPROXIMATELY ONE HALF INCH PAST THE TERMINAL PIN ON THE LEAD BODY. THE LEAD WAS REMOVED FROM SERVICE AND SURGICALLY ABANDONED. A NEW GUIDANT SYSTEM WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERVENE LEAD | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS | 497-23 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | THE DEVICE 0148/114846 WAS IMPLANTED 31-OCT-2001| THE DEVICE 4472/300771 WAS IMPLANTED 31-OCT-2001| THE DEVICE 1861/216568 WAS IMPLANTED 31-OCT-2001| THE DEVICE 101-/01564 WAS IMPLANTED 26-AUG-1998 |