FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 1004027
·
Received February 25, 2008
Report
- Report Number
- 1028232-2008-00128
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- December 6, 2007
- Report Date
- January 30, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFO THAT THIS IMPLANTABLE RIGHT ATRIAL PACING LEAD DISLODGED. LOSS OF CAPTURE WAS ALSO REPORTED. IT WAS LATER REPORTED THAT THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH AN EPICARDIAL LEAD. IT WAS NOTED UPON REMOVAL OF THE LEAD THAT THE HELIX MECHANISM WAS NOT FULLY EXTENDED OUT OF THE LEAD TIP CAUSING THE LEAD TO NOT COMPLETELY SCREW INTO THE ENDOCARDIUM. TO DATE, THERE HAVE BEEN NO REPORTED PT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS 4136 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO | 358754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |