FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 1991252
·
Received February 15, 2011
Report
- Report Number
- 6000094-2011-00256
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- November 17, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 THAT THE DEVICE DETECTED AN IRREGULAR SINUS RHYTHM AS ATRIAL FIBRILLATION. MAXIMUM AUTO DETECTED EPISODES REACHED AND THE DEVICE WAS PROGRAMMED OFF. THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVEAL XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC S.A. | 9529 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |