FDA Adverse Event
Injury
Summary report: N
CYLOS DR-T
MDR report key: 1221853
·
Received November 3, 2008
Report
- Report Number
- 1028232-2008-01294
- Event Type
- Injury
- Date Received
- November 3, 2008
- Date of Event
- September 11, 2008
- Report Date
- October 1, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION: CYLOS DR-T, MDR 1028232-2008-01294. SELOX ST 60, MDR 1028232-2008-01295. SETROX S 45, MDR 1028232-2008-01296.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYLOS DR-T | PACEMAKER | DXY | BIOTRONIK GMBH AND CO. | 349806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |