FDA Adverse Event
Injury
Summary report: N
ESTELLA DR-T
MDR report key: 3083050
·
Received April 29, 2013
Report
- Report Number
- 1028232-2013-01154
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 14, 2013
- Report Date
- April 18, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DXY
- PMA / PMN Number
- P950037
- 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
PER BIOSMART, THIS SYSTEM WAS REMOVED DUE TO A FOOT INFECTION. THERE IS NO INDICATION THAT THE SYSTEM WAS REPLACED. 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 |
|---|---|---|---|---|---|---|---|
| 183596 | ESTELLA DR-T | PACEMAKER | DXY | BIOTRONIK SE & CO. KG | 371207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |