FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 3213087
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10448
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 13, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ROUTINE DEVICE CHECK, THIS PACEMAKER SHOWED A REMAINING LONGEVITY OF 3.5 YEARS. HOWEVER, AT THE PREVIOUS FOLLOW-UP SIX MONTHS AGO, THE REMAINING LONGEVITY HAD BEEN GREATER THAN FIVE YEARS. LEAD MEASUREMENTS REMAINED STABLE, WITHOUT ANY SIGNIFICANT CHANGES IN PACING PERCENTAGES. A REASON FOR THE EARLY BATTERY DEPLETION COULD NOT BE DETERMINED, SO THE PATIENT WAS SCHEDULED FOR ANOTHER DEVICE CHECK IN THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313047 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |