FDA Adverse Event
Malfunction
Summary report: N
INSYNC SENTRY
MDR report key: 2953162
·
Received February 9, 2013
Report
- Report Number
- 9614453-2013-00195
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 26, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P010031
- 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 THE SAME/SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS POSSIBLE EARLY 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 |
|---|---|---|---|---|---|---|---|
| 56412 | INSYNC SENTRY | LWS | IPG MFG SWITZERLAND | 7298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR |