FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 3210371
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07666
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 16, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 THIS PACEMAKER'S MAGNET RATE WAS 100 PPM, BUT OVER A YEAR AGO THE MAGNET RATE WAS 90 PPM. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AS TO WHY THIS MIGHT OCCUR. TS THE DIFFERENT VARIABLES THAT CAN AFFECT THE MAGNET RATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE SYSTEM REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310558 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 4024| MISMATCH| 5524M| 1297 |