FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 3153203
·
Received June 8, 2013
Report
- Report Number
- 9614453-2013-01135
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 29, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, NL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY #THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE IMPLANTABLE CARDIAC MONITOR POCKET WHEN EXERCISING. THE ICM WAS REMOVED AND NOT REPLACED. THE PATIENT IS A PARTICIPANT IN THE (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256043 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR | Hospitalization| R |