FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 1004022
·
Received February 25, 2008
Report
- Report Number
- 1028232-2008-00145
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- December 10, 2007
- Report Date
- January 29, 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 INFORMATION THAT THIS PACEMAKER AND LEAD SYSTEM WAS EXPLANTED DUE TO A PATIENT INFECTION. A NEW SYSTEM WAS IMPLANTED AT A LATER TIME. NO PRODUCT PERFORMANCE ISSUE WAS REPORTED.
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 |