FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 2910354
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16007
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- November 1, 2012
- Report Date
- November 1, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IN SERVICE WITH PROGRAMMING CHANGE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOSS OF CAPTURE (LOC) THAT RESULTED IN ASYSTOLE FOR TWO SECONDS OBSERVED DURING A ROUTINE DEVICE CHECK. THERE WERE NO ADVERSE PATIENT EFFECTS. PROGRAMMING CHANGES WERE MADE TO INCREASE OUTPUTS TO RESOLVE ISSUE. ALL OTHER MEASUREMENTS WERE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17712 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 1230| 4285| 1291| 4269| 1298 |