FDA Adverse Event
Malfunction
Summary report: N
INGENIO
MDR report key: 3913533
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-13457
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 13, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION, THIS PACEMAKER¿S BATTERY LONGEVITY HAD SIGNIFICANTLY DECREASED TO 8.5 YEARS FROM 15.5 YEARS. ATRIAL FIBRILLATION WAS OBSERVED ON ELECTROGRAM (EGM) AND THE FIELD REPRESENTATIVE FURTHER CONFIRMED THIS AS THE CAUSE OF THE PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS REPROGRAMMED RESULTING TO INCREASED LONGEVITY TO 9.0 YEARS. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390718 | INGENIO | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | J174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | J174 |