FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1855071
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04370
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- August 12, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 PATIENT'S DEVICE HAD A LOW BATTERY VOLTAGE AND HAD REACHED IT ELECTIVE REPLACEMENT INTERVAL (ERI). THE PHYSICIAN REMOVED AND REPLACED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 4574 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD |