FDA Adverse Event
Injury
Summary report: N
LINOX SMART PROMRI S DX 65/17
MDR report key: 4211007
·
Received October 29, 2014
Report
- Report Number
- 1028232-2014-003756
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- February 20, 2014
- Report Date
- October 14, 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. CONCLUSIONS REGARDING THE CLINICAL OBSERVATION CANNOT BE DRAWN FOR THE TIME BEING. THE ANALYSIS WILL CONTINUE AS SOON AS NEW INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
OUS MDR - A LOSS OF ATRIAL SENSING AND INCREASED VENTRICULAR PACING THRESHOLD WAS DETECTED. A RV LEAD DISLODGEMENT WAS DIAGNOSED. THE REVISION WAS SUCCESSFULLY PERFORMED DURING A HOSPITAL STAY FROM (B)(6) 2014. REGULAR ICD FUNCTION WAS NOTED AT DISCHARGE. REVISION PERFORMED WITHOUT COMPLICATIONS ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691610 | LINOX SMART PROMRI S DX 65/17 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 377212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |