FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ MOBILE MANAGER APP
MDR report key: 10120392
·
Received June 4, 2020
Report
- Report Number
- 2182208-2020-01031
- Event Type
- Malfunction
- Date Received
- June 4, 2020
- Date of Event
- May 7, 2020
- Report Date
- July 10, 2020
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DSI
- PMA / PMN Number
- K150614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 DIAGNOSTIC MOBILE PROGRAMMER APPLICATION FAILED TO PROGRAM THE PATIENTS IMPLANTED DEVICE ON. THE USER INDICATES THE PATIENT WILL RETURN TO THE CLINIC TO RESOLVE THE ISSUE. THE CURRENT STATUS OF THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE REMOTE MONITOR HAD MISSED DAILY WIRELESS AUDITS (DWA). IT WAS FOUND OUT THAT THE DEVICE APPEARED NOT TO HAVE BEEN PROGRAMMED ON. THE MONITOR 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 |
|---|---|---|---|---|---|---|---|
| 585181 | REVEAL LINQ MOBILE MANAGER APP | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC, INC. | LMM-GENERAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |