FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 3050943
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05916
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN ON THE LEFT SIDE WHERE THE DEVICE IS IMPLANTED. THE PATIENT INDICATED HAVING SORE MUSCLES IN NECK, BACK, AND CHEST AND WAS WONDERING IF THERE WAS AN INFECTION. THE PATIENT ALSO INDICATED THAT THE DEVICE HAD TWISTED UNDER THE SKIN AND SOMETIMES PUSHES OUT 0.5 INCH. THE PHYSICIAN'S OFFICE WAS CONTACTED, BUT THEY HAD NOT SEEN THE PATIENT. 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 |
|---|---|---|---|---|---|---|---|
| 148904 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |