FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS 4135
MDR report key: 4152107
·
Received October 8, 2014
Report
- Report Number
- 1028232-2014-003530
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 13, 2014
- Report Date
- September 24, 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 ATRIAL LEAD EXHIBITED HIGH PACING THRESHOLDS. THIS RA LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AS THE LEAD WAS SURGICALLY ABANDONED, 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 |
|---|---|---|---|---|---|---|---|
| 630355 | DEXTRUS 4135 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 358744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |