FDA Adverse Event
Injury
Summary report: N
AROX 53-BP
MDR report key: 1211778
·
Received October 24, 2008
Report
- Report Number
- 1028232-2008-01308
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- July 30, 2008
- Report Date
- September 26, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- K021217
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION: CYLOS DR-T, MDR 1028232-2008-01306. AROX 45-JBP, MDR 1028232-2008-01307. AROX 53-BP, MDR 1028232-2008-01308.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AROX 53-BP | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 338023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |