FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 2812128
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06640
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- February 23, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
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 THERE WERE EPISODES OF INTERMITTENT T-WAVE OVERSENSING AND OCCASIONAL NOISE. THE PATIENT WILL HAVE THE IMPLANTABLE LOOP RECORDER (ILR) REPROGRAMMED IN THE NEAR FUTURE AND CALLER WAS LOOKING FOR SUGGESTIONS TO DECREASE OVERSENSING. IT WAS ALSO NOTED THAT THE PATIENT HAS OCCASIONAL ECTOPIC HEART BEATS. THE ILR 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 | REVEAL XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |