FDA Adverse Event
Malfunction
Summary report: N
REVEAL XT
MDR report key: 2955230
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-01850
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- September 11, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD ELEVEN ASYSTOLE EPISODES. ALL EPISODES WERE DUE TO LOSS OF ELECTRODE CONTACT. THESE EPISODES SHOULD BE LESS FREQUENT AS THE POCKET DEVELOPS MORE TISSUE AROUND THE DEVICE. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 59944 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR |