FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 2911917
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-17305
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 3, 2012
- Report Date
- December 4, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PER OUR RECORDS THIS DEVICE WAS EXPLANTED. IT IS UNKNOWN IF IT WILL BE RETURNED. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR IF THE DEVICE IS RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD A REPORTED SYNCOPAL EPISODE THAT RESULTED IN ADMISSION TO THE HOSPITAL. IT IS UNDETERMINED IF THE EPISODE WAS RELATED TO THE DEVICE FUNCTION. THE DEVICE WAS INTERROGATED AND DISPLAYED THE END OF LIFE (EOL) INDICATOR. THE PATIENT IS REPORTED BEING PACE MAKER DEPENDENT. A REQUEST FOR ADDITIONAL INFORMATION AND DEVICE RETURN HAS BEEN SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16456 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | 4086| 5076| 1298 |