FDA Adverse Event
Injury
Summary report: N
LINOX SMART PROMRI S 65
MDR report key: 4250587
·
Received November 14, 2014
Report
- Report Number
- 1028232-2014-004089
- Event Type
- Injury
- Date Received
- November 14, 2014
- Date of Event
- April 30, 2014
- Report Date
- November 5, 2014
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
OUS MDR - IT WAS REPORTED THAT 41 DAYS AFTER THE IMPLANTATION THIS RIGHT VENTRICULAR LEAD DISLODGED. THE THRESHOLD INCREASED FROM 1.2V AT 0.4 MS UP TO 7.5V AT 1.5MS AND THE SENSING DECREASED FROM 7.8 MV TO 1.2 MV. THE LEAD WAS SUCCESSFULLY REPOSITIONED. APART FROM HOSPITALIZATION AND REVISION PROCEDURE, NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737400 | LINOX SMART PROMRI S 65 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 377166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |