FDA Adverse Event
Malfunction
Summary report: N
MERIDIAN
MDR report key: 1950566
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22756
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- GUIDANT CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- P940031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INTERVENTION WAS UNDERTAKEN. THIS REPORT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE UPGRADE PROCEDURE FOR NORMAL BATTERY DEPLETION, WHEN BOTH SETSCREWS OF THE DEVICE WERE LOOSENED ONE OF THE LEADS BROKE APART ONCE REMOVED FROM THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDIAN | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CLONMEL IRELAND | 0476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 4137| (B)(4)| 0476| S601| (B)(4) |