FDA Adverse Event
Malfunction
Summary report: N
BIOPORE
MDR report key: 2173321
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10533
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD IMPLANTED GREATER THAN 24 YEARS, WAS DISCONNECTED FROM THE IMPLANTED DEVICE DURING AN ELECTIVE PROCEDURE; HOWEVER, FOLLOWING CONNECTION WITH THE NEW DEVICE, THE TERMINAL PIN WAS EASILY REMOVED FROM THE HEADER. THE DISTAL AND PROXIMAL CONNECTORS OF THE LEAD WERE THEN CONFIRMED DETACHED. THE LEAD WAS REMOVED FROM SERVICE AND ANOTHER LEAD SUCCESSFULLY IMPLANTED IN THE ABSENCE OF ADVERSE PATIENT EFFECTS OR PRODUCT ALLEGATIONS. THE EXPLANTED LEAD WILL NOT BE RETURNED FOR A POST MARKET ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPORE | IMPLANTABLE LEAD | NVN | GUIDANT ANGLETON/ST. PAUL | 430-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | (B)(4)| (B)(4)| (B)(4) |