FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS 4137
MDR report key: 6196015
·
Received December 21, 2016
Report
- Report Number
- 1028232-2016-05027
- Event Type
- Malfunction
- Date Received
- December 21, 2016
- Date of Event
- November 22, 2016
- Report Date
- December 5, 2016
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- 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
BSX PROVIDED THE FOLLOWING INFORMATION: RV LEAD THRESHOLDS ELEVATED. DECISION WAS MADE BY MD TO PLACE NEW RV LEAD AT TIME OF GENERATOR CHANGE. THE RV AMPLITUDE WAS PROGRAMMED HIGH ON THE DEVICE SO IT IS BELIEVED THAT THE THRESHOLDS CONTINUED TO RISE OVER THE YEARS AND SINCE BATTERY WAS AT ERI THEY ELECTED TO PLACE A NEW LEAD WHEN THE GENERATOR WAS CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844048 | DEXTRUS 4137 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 358764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |