FDA Adverse Event
Injury
Summary report: N
SETRXO S 45
MDR report key: 2842029
·
Received November 15, 2012
Report
- Report Number
- 1028232-2012-02869
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- September 21, 2012
- Report Date
- November 1, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED AND REPLACED DUE TO ADHESIONS AND KELOID SCARRING. THE PATIENT WAS COMPLAINING OF EXTREME PAIN. 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 | SETRXO S 45 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization |