FDA Adverse Event
Injury
Summary report: N
CYLOS DR-T
MDR report key: 1092685
·
Received August 1, 2008
Report
- Report Number
- 1028232-2008-00809
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- June 3, 2008
- Report Date
- July 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
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS SYSTEM WAS REMOVED DUE TO EROSION. SYSTEM REMOVED: CYLOS DR-T, MDR 1028232-2008-00809. SETROX S 45, MDR 1028232-2008-00810. SETROX S 53, MDR 1028232-2008-00811.
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 | 77 YR | Hospitalization |