FDA Adverse Event
Malfunction
Summary report: N
REVEAL DX
MDR report key: 1921256
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05717
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- August 6, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071655
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 ONLY 2 OF 8 EPISODES COULD BE VIEWED ON CARELINK, AND THEY WERE BOTH CONSISTENT WITH ARTIFACT (OVERSENSING RESULTING IN FAST VENTRICULAR TACHYCARDIA). THE PATIENT REPORTED THAT THEIR HEART "STOPPED" AND THAT THEY WERE HOSPITALIZED IN THE SAME TIMEFRAME AS THE EPISODES. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |