FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 7519922
·
Received May 16, 2018
Report
- Report Number
- 9614453-2018-01908
- Event Type
- Malfunction
- Date Received
- May 16, 2018
- Date of Event
- April 19, 2018
- Report Date
- May 16, 2018
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- DSI
- UDI-DI
- 00643169323575
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONTINUATION OF CONCOMITANT PRODUCTS: PRODUCT ID 24950D1, SERIAL# (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMOTE MONITOR HAD A UNSUCCESSFUL DAILY WIRELESS AUDIT (DWA). IT WAS VERIFIED THAT NO TROUBLESHOOTING WAS DONE. THE PATIENT WAS ADVISED TO CALL THE CLINIC AND HAVE A DEVICE CHECK DUE TO DEPLETED BATTERY LIFE. 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 |
|---|---|---|---|---|---|---|---|
| 362510 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC EUROPE SARL | LNQ11 | 00643169323575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |