FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 4161789
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02251
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 21, 2014
- Report Date
- July 21, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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. CONCOMITANT PRODUCTS: 39565-65 PAIN STIM LEAD (B)(6) 2012; 37714 PAIN STIM IPG (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A STORED EPISODE APPED TO HAVE INTERMITTENT UNDERSENSING. 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 |
|---|---|---|---|---|---|---|---|
| 640227 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | 3550-39 NEURO ADAPTOR |