FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 4152113
·
Received October 8, 2014
Report
- Report Number
- 1028232-2014-003539
- Event Type
- Injury
- 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
- 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 DISLODGED. THIS LEAD WAS PROGRAMMED OFF AS THIS PATIENT DOES NOT REQUIRE ATRIAL PACING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IMPLANTED. 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 |
|---|---|---|---|---|---|---|---|
| 630357 | DEXTRUS 4136 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 358754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |