FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS 4137
MDR report key: 3984443
·
Received August 6, 2014
Report
- Report Number
- 1028232-2014-002729
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- June 9, 2014
- Report Date
- July 23, 2014
- 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
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING THRESHOLD OF 3.1 VOLTS (V) AT 0.5 MILLISECONDS. THIS RV LEAD WAS REPOSITIONED AND ALL LEAD MEASUREMENT WAS IN NORMAL LIMITS. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461192 | DEXTRUS 4137 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 358764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |