FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 3232702
·
Received July 18, 2013
Report
- Report Number
- 2124215-2013-11191
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 20, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 IMPLANTABLE PACEMAKER DEPLETED FASTER THAN EXPECTED. ACCORDING TO THE HEALTH CARE PROFESSIONAL (HCP), THE DEVICE WAS CHECKED IN (B)(6) 2012 AND HAD ONE YEAR REMAINING ON THE BATTERY; HOWEVER, SIX MONTHS LATER THE DEVICE DISPLAYED PLACEMENT INDICATORS. THE DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR¿S PRODUCT. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334534 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 1290| 4469| MISMATCH |