FDA Adverse Event
Injury
Summary report: N
SETROX S 53
MDR report key: 1031277
·
Received April 18, 2008
Report
- Report Number
- 1028232-2008-00375
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 18, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS LEAD WAS NOT RETURNED, HOWEVER, REPORTER SENT IN THE OOS DOCUMENTATION WITH THE DEVICE. THIS SYSTEM WAS REMOVED DUE TO INFECTION. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT. ALSO ASSOCIATED WITH THIS SYSTEM: SETROX S 45 MDR: 1028232-2008-00373; CYLOS DR-T MDR: 1028232-208-00374.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |