FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4135
MDR report key: 1231654
·
Received November 14, 2008
Report
- Report Number
- 1028232-2008-01433
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- September 19, 2008
- Report Date
- October 17, 2008
- Manufacturer
- BIOTRONIK, GMBH & CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PACE/SENSE LEAD WAS EXPLANTED DUE TO INFECTION. THERE WERE NO ALLEGATIONS AGAINST THE FUNCTION OF THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS 4135 | PACER LEAD | DTB | BIOTRONIK, GMBH & CO. | 358744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |