FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2060085
·
Received April 15, 2011
Report
- Report Number
- 2124215-2011-06641
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- April 1, 2011
- Report Date
- March 31, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PACEMAKER REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED UNDERSENSING, LOSS OF CAPTURE (LOC) AND RIGHT VENTRICULAR (RV) THRESHOLD ISSUES. THE LEAD IMPEDANCE MEASUREMENTS WERE STABLE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED OTHER THAN THE PATIENT COMPLAINING OF INTERMITTENT CHEST PAIN. THE DECISION WAS MADE TO REPROGRAM THE DEVICE. IT SHOULD BE NOTED THE ASSOCIATED RV LEAD IS A COMPETITOR PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | 1888TC| S501 |