ENRHYTHM
Report
- Report Number
- 3004209178-2013-08906
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- June 19, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Removal / Correction Number
- Z-1440-2010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. IT WAS ALSO NOTED THAT THERE WAS A TELEMETRY PROBLEM AND THE PATIENT WAS UNABLE TO TRANSMIT VIA REMOTE MONITORING TRANSMISSION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. IT WAS ALSO NOTED THAT THERE WAS A TELEMETRY PROBLEM AND THE PATIENT WAS UNABLE TO TRANSMIT VIA REMOTE MONITORING TRANSMISSION. 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 |
|---|---|---|---|---|---|---|---|
| 254989 | ENRHYTHM | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | P1501DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |