FDA Adverse Event
Injury
Summary report: N
SENSIA SR
MDR report key: 3991849
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01667
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- April 5, 2014
- Report Date
- June 2, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND DID NOT MEET EXPECTED LONGEVITY. THE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 467712 | SENSIA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |