FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 4223919
·
Received November 4, 2014
Report
- Report Number
- 1028232-2014-004061
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 13, 2014
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
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 LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708362 | SETROX S 45 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization |