FDA Adverse Event
Injury
Summary report: N
REVEAL XT
MDR report key: 3153262
·
Received June 8, 2013
Report
- Report Number
- 9614453-2013-01136
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- November 29, 2011
- Report Date
- April 2, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K103764
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY:THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND DETERMINED THAT IT WAS NOT REQUIRED TO SUPPORT THE COMPLAINT.
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED DUE TO SKIN EROSION AND POCKET PERFORATION. THE PATIENT IS A PARTICIPANT IN THE INSIGHT XT CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255117 | REVEAL XT | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | 9529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Hospitalization| R |