FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 1950865
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22764
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PACING OUTPUT WAS REPROGRAMMED TO THE MAXIMUM SETTING AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE DUE TO A PACING FAILURE. INTERROGATION OF THE DEVICE INDICATED THE PACING FAILURE WAS LOSS OF CAPTURE CAUSED BY A RAPID RISE IN PACING THRESHOLD. THE PACING OUTPUT WAS INCREASED. HOWEVER, A FURTHER THRESHOLD INCREASE AND LOSS OF CAPTURE WAS NOTED SEVERAL DAYS LATER. NO FURTHER PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |