FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 1771599
·
Received July 27, 2010
Report
- Report Number
- 2124215-2010-13662
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- September 28, 2009
- Report Date
- June 7, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS FIELD REPRESENTATIVE (FR) REPORTED THIS DEVICE WITH HIGH VENTRICULAR OUTPUTS HAS AN ESTIMATED LONGEVITY REMAINING OF LESS THAN 0.5 YEARS, HOWEVER THE BATTERY INDICATOR STILL SHOWS 3/4 FULL. THE PATIENT IS PACED 100 PERCENT. TECHNICAL SERVICES DISCUSSED WITH HIGH OUTPUTS, THE DEVICE LONGEVITY SHOULD BE BELIEVED OVER THE BATTERY INDICATOR. THE FR AGREED AND WILL NOTIFY THE CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | 4470| 1291| 4469 |