FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 2905457
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-13430
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- October 2, 2012
- Report Date
- January 17, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION IS EXPECTED REGARDING THIS ISSUE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.
Additional Manufacturer Narrative · 1
SHOULD THE DEVICE BE RETURNED, ANALYSIS WILL BE COMPLETED AND ANOTHER REPORT FILED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER REACHED ELECTIVE REPLACEMENT TIME (ERT) SOONER THAN EXPECTED DUE TO HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLD MEASUREMENTS ON A NON-BSC RV LEAD. PREMATURE BATTERY DEPLETION WAS SUSPECTED. IT IS LIKELY THAT BOTH THE DEVICE AND THE LEAD WILL BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON BOSTON SCIENTIFIC PRODUCT. NO REPORTED ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12929 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |