FDA Adverse Event
Malfunction
Summary report: N
VITA II D
MDR report key: 3860025
·
Received June 10, 2014
Report
- Report Number
- 6000095-2014-00004
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 8, 2014
- Manufacturer
- VITATRON MEDICAL B.V.
- Product Code
- DXY
- PMA / PMN Number
- P990001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD PREMATURE BATTERY DEPLETION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340206 | VITA II D | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | VITATRON MEDICAL B.V. | VA730U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR |