FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2162660
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07178
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO FURTHER INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMAITON BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, IMPLANTED WITH THIS PACEMAKER WAS SHOWING A HISTORY OF NOISE, OVERSENSING WITH PACING INHIBITION OVER THE PAST THREE MONTHS. THE VENTRICULAR SENSITIVITY SETTINGS WERE REPROGRAMMED TO PREVENT OVERSENSING. TECHNICAL SERVICES SUSPECTS A LEAD ISSUE AND RECOMMENDED ADDRESSING THIS AS THE PATIENT IS PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | (B)(4)| S603| (B)(4)| 1184| 4135 |