FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 3071648
·
Received April 22, 2013
Report
- Report Number
- 9614453-2013-01020
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 14, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT OF AN IMPLANTABLE CARDIAC MONITOR (ICM), THE PATIENT HAD A SYMPTOMATIC EPISODE THAT APPEARED NOT TO BE CAPTURED ON THE ICM. NOISE WAS ALSO FOUND ON THE STORED DATA. THE ICM WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173082 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |