FDA Adverse Event
Injury
Summary report: N
COROX OTW-L 85-BP
MDR report key: 2893977
·
Received December 21, 2012
Report
- Report Number
- 1028232-2012-03355
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 7, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- OJX
- PMA / PMN Number
- P070008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. IT IS BELIEVED THAT THE PATIENT CAUGHT THE INFECTION FROM DIALYSIS. THERE IS NO INDICATION THAT THE SYSTEM HAS BEEN REPLACED YET. THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROX OTW-L 85-BP | LV LEAD | OJX | BIOTRONIK SE & CO. KG | 368346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |