FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM DR
MDR report key: 2051918
·
Received April 12, 2011
Report
- Report Number
- 6000094-2011-00511
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- September 22, 2009
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI) A DAY AFTER IMPLANT. INTERROGATION SHOWED THE DEVICE HAD OUTPUT SINCE APPROXIMATELY A YEAR AND A HALF PRIOR TO IMPLANT. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 | Other |