FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 2041417
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01109
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 31, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.
Description of Event or Problem · 1
ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE CHECK UP, THE BATTERY STATUS SHOWED 3.5 YEARS REMAINING. THE PRIOR DEVICE CHECK LESS THAN A YEAR AGO STATED GREATER THAN 5 YEARS REMAINING. THERE IS CONCERN THAT THE DEVICE MAY BE DEPLETING PREMATURELY. NO ADVERSE 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 | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 4456| 4479| 1290 |