FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4135
MDR report key: 4110392
·
Received September 23, 2014
Report
- Report Number
- 1028232-2014-003377
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- July 29, 2014
- Report Date
- September 12, 2014
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- 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
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD HAD DISLODGED. THE LEADS DISLODGEMENT WAS DETECTED THROUGH NORMAL FOLLOW UP AND WAS CONFIRMED VIA X-RAYS. THIS LEAD WAS SCHEDULED TO BE REPOSITIONED. 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 |
|---|---|---|---|---|---|---|---|
| 591409 | DEXTRUS 4135 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 358744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |