FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1925133
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06220
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THAT A POWER ON RESET (POR) OCCURRED. IT WAS NOTED THAT THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NOTED PER CARELINK ON (B)(6) 2010 TO HAVE "RESET". PATIENT WENT TO CLINIC FOR REPROGRAMMING. 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 MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 5076 X2 IMPLANTABLE PACING LEAD |