FDA Adverse Event
Injury
Summary report: N
VITA 2 S
MDR report key: 3990585
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01780
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 23, 2014
- Report Date
- June 23, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DXY
- PMA / PMN Number
- P990001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND 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) BATTERY DEPLETED AND IS SUSPECTED AS PREMATURE BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467524 | VITA 2 S | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | IPG MFG SWITZERLAND | VA230U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Hospitalization| R |