FDA Adverse Event
Injury
Summary report: N
SELOX ST 53
MDR report key: 1151389
·
Received September 4, 2008
Report
- Report Number
- 1028232-2008-01074
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- May 8, 2008
- Report Date
- August 6, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER BIOTRONIK REPRESENTATIVE SABRINA VINTERFELD, THIS LEAD WAS IMPLANTED; AFTER THE PATIENT WAS SEWED UP, IT WAS NOTICED THAT THE LEAD HAD HIGH IMPEDANCES AND THE PHYSICIAN HAD SPLIT THE LEAD. THE PATIENT WAS REOPENED AND THE LEAD WAS REPLACED WITH ANOTHER SELOX ST 53.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 346366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |