FDA Adverse Event
Injury
Summary report: N
DA+ T SERIES DR
MDR report key: 2201662
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01335
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P990001/S15
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET. THE DEVICE WAS REPROGRAMMED AND REMAINS 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 | DA+ T SERIES DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | T60A1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other | 4592 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD |