FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 1142733
·
Received August 26, 2008
Report
- Report Number
- 1028232-2008-01006
- Event Type
- Injury
- Date Received
- August 26, 2008
- Date of Event
- June 11, 2008
- Report Date
- July 25, 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 CRM RECEIVED INFO THAT THIS RIGHT ATRIAL LEAD DISLODGED. THE LEAD WAS REPOSITIONED ONE DAY AFTER THE IMPLANT PROCEDURE.
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 | UNK | Hospitalization |