FDA Adverse Event
Injury
Summary report: N
REVEAL LINQ
MDR report key: 3991415
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01703
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 9, 2014
- Report Date
- June 13, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
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 APPROXIMATELY TEN DAYS AFTER IMPLANT OF THE IMPLANTABLE CARDIAC MONITOR THE DEVICE CAME OUT OF THE POCKET. NO P ATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470007 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Required Intervention |