ENRHYTHM MRI
Report
- Report Number
- 9614453-2013-00949
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- January 14, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED HIGH IMPEDANCE IN THE BATTERY. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT THE DEVICE BATTERY IMPEDANCE WAS OUT OF RANGE HIGH AND CAUSED ELECTIVE REPLACEMENT INDICATOR (ERI). THE ERI DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON (B)(6) 2012, PRIOR TO EXPLANT, (B)(4) INSTALLED ON (B)(6) 2011.
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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND RETURNED PRODUCT ANALYSIS IS PENDING. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT THE DEVICE BATTERY IMPEDANCE WAS OUT OF RANGE HIGH AND CAUSED ELECTIVE REPLACEMENT INDICATOR (ERI). THE ERI DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON 7/6/2012, PRIOR TO EXPLANT, RAMWARE VERSION 8 INSTALLED ON (B)(6) 2011. (B)(4).
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED HIGH IMPEDANCE IN THE BATTERY. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT THE DEVICE BATTERY IMPEDANCE WAS OUT OF RANGE HIGH AND CAUSED ELECTIVE REPLACEMENT INDICATOR (ERI). THE ERI DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON (B)(6) 2012, PRIOR TO EXPLANT, (B)(4) INSTALLED ON (B)(6) 2011.
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149822 | ENRHYTHM MRI | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | EMDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | Hospitalization| R |