FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 2812500
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06356
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 20, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 WAS OVERSENSING AND UNDERSENSING CAUSING FALSE EPISODE COLLECTION. THE SENSING VALUE WAS NOTED TO BE LOW. THE DEVICE WAS PLACED IN THE LEFT SUBCLAVIAN AREA, A LITTLE LOWER THAN A PACEMAKER POCKET AREA. 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 XT | IMPLANTABLE LOOP RECORDER | DSI | MEDTRONIC MED REL, INC. | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |