FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 2151737
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06268
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS REMOVED ALONG WITH THE NON-BOSTON SCIENTIC LEADS DUE TO POCKET EROSION. THE DEVICE WAS SUSPECTED TO HAVE BEEN SHIFTED DUE TO A PREVIOUS MOTORCYCLE ACCIDENT, AND AT THE TIME OF EXPLANT WAS HALF WAY OUT OF THE POCKET. DURING THE SURGERY TO REMOVE THE PATIENT SYSTEM, A LASER PERFORATED THE HEART. OPEN HEART SURGERY WAS PERFORMED TO FIX THE HOLE AND REMOVE THE REST OF THE SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE PROLONGED SURGURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| L| R | 1297| 1188T| 1488TC| MISMATCH |