FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 2951850
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01620
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 9, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DSI
- PMA / PMN Number
- K071641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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 THERE WERE OVER 9500 EPISODES OF NOISE RECORDED ON THE IMPLANTABLE CARDIAC MONITOR. IT WAS NOTED THAT THE DEVICE IS NOT SUTURED IN THE POCKET. 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 |
|---|---|---|---|---|---|---|---|
| 55735 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |