FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 2153126
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06396
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- D970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF THIS REPORT, THE SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS OBSERVED ON THIS RIGHT VENTRICULAR LEAD CAUSING OVERSENSING AND PACING INHIBITION. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE HAD NO FURTHER INFORMATION REGARDING IF THE PATIENT WAS SYMPTOMATIC OR IF FURTHER ACTION WOULD BE TAKEN BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | 5076| 1296 |