FDA Adverse Event
Malfunction
Summary report: N
REVEAL DX
MDR report key: 1792472
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03267
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- May 6, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071655
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THE COLLECTED FVT SHOWED MANY NON-PHYSIOLOGIC INTERVALS AND THERE APPEARED TO BE NOISE THROUGH THE ECG RECORDING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 | 36 YR | Other |