FDA Adverse Event
Injury
Summary report: N
DA+ T SERIES DR
MDR report key: 2532635
·
Received April 12, 2012
Report
- Report Number
- 6000094-2012-00865
- Event Type
- Injury
- Date Received
- April 12, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- 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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET. THE DEVICE WAS RESTORED 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 | NVZ | MEDTRONIC S.A. | T70A1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |