FDA Adverse Event
Injury
Summary report: N
REVEAL DX
MDR report key: 2812132
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06443
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071655
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 THE PATIENT HAD SEVERAL BRADYCARDIA EPISODES AND THE DEVICE WAS UNDERSENSING. THE SENSITIVITY SETTINGS WERE CHANGED AND THE DEVICE 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 DX | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |