FDA Adverse Event
Injury
Summary report: N
SENSIA SR
MDR report key: 4161539
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02273
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- June 23, 2014
- Report Date
- July 3, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. 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) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND EARLY BATTERY DEPLETION IS SUSPECTED. 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 |
|---|---|---|---|---|---|---|---|
| 640934 | SENSIA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |