FDA Adverse Event
Malfunction
Summary report: N
LINOX SMART S 65
MDR report key: 2639855
·
Received June 27, 2012
Report
- Report Number
- 1028232-2012-01685
- Event Type
- Malfunction
- Date Received
- June 27, 2012
- Date of Event
- May 7, 2012
- Report Date
- June 19, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR.
Description of Event or Problem · 1
OUS MDR - DURING A SCHEDULED F/U ON (B)(6) 2012 A LOSS OF SENSING WAS NOTED. SOMETIME AFTER THE IMPLANTATION IN (B)(6) 2011 UP TO LAST F/U IN (B)(6) 2011 SENSING HAS BEEN ABOUT 10 MV. F/U IN (B)(6) 2012 SHOWED AN R-WAVE OF 3 MV. THESE VALUES HAVE BEEN MEASURED SINCE THEN. ON (B)(6) 2012, THIS LEAD WAS EXPLANTED AND A NEW ONE WAS IMPLANTED. THE IMPLANT AND EXPLANT DATES WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SMART S 65 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 369818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |