FDA Adverse Event
Injury
Summary report: N
LINOX SMART PROMRI S 65
MDR report key: 4223033
·
Received November 4, 2014
Report
- Report Number
- 1028232-2014-003969
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- October 17, 2014
- Report Date
- October 24, 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 - THIS LEAD WAS FOUND TO BE DISLODGED AT A ROUTINE FOLLOW-UP. NO DATE OF EXPLANT WAS PROVIDED AND THERE WAS NO INDICATION OF INTERVENTION. THIS IS ALL OF THE AVAILABLE INFORMATION AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708159 | LINOX SMART PROMRI S 65 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 377166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |