FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 3993268
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01911
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 28, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
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 AN INTERROGATION OF THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE SHOWED UNDERSENSING DUE TO SMALL R-WAVES. THE OCCASIONAL UNDERSENSING WAS CAUSING THE DEVICE TO SENSE BRADY EVENTS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469341 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |