FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 4831505
·
Received June 10, 2015
Report
- Report Number
- 9614453-2015-01194
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- April 1, 2015
- Report Date
- April 2, 2015
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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, UPON INTERROGATION DURING THE INITIAL IMPLANT PROCEDURE, THE ILR (IMPLANTABLE LOOP RECORDER) HAD SENSING ISSUES OF NOISE. THE DEVICE WAS REPOSITIONED AT LEAST TWICE. THIS DID NOT RESOLVE THE PROBLEM. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379444 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR |