FDA Adverse Event
Malfunction
Summary report: N
SETROX S 53
MDR report key: 4211043
·
Received October 29, 2014
Report
- Report Number
- 1028232-2014-003866
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- October 2, 2014
- Report Date
- October 14, 2014
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- 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 CAPPED AND REPLACED DUE TO LOW IMPEDANCES OF LESS THAN 150 OHMS. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692474 | SETROX S 53 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization |