FDA Adverse Event
Malfunction
Summary report: N
REVEAL DX
MDR report key: 1925017
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06185
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K071655
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
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
THE PATIENT REPORTED THAT THERE IS A FEELING OF DULL PAIN AROUND IMPLANT SITE. PATIENT SAYS DEVICE DOES NOT LAY FLAT AS IT USE TO, IT KIND OF PROTRUDES. DEVICE IS STILL IN USE. NO FURTHER 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 | 88 YR | Other |