FDA Adverse Event
Injury
Summary report: N
DA+ T SERIES SR
MDR report key: 1992353
·
Received February 15, 2011
Report
- Report Number
- 6000094-2011-00310
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- December 22, 2010
- 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
- UK
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT RECEIVED A RADIO FREQUENCY ABLATION PROCEDURE AND THE BIPOLAR IMPEDANCE INCREASED TO GREATER THAN 2000 OHMS. THE DEVICE WAS REPROGRAMMED. 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 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | T20A1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |