FDA Adverse Event
Malfunction
Summary report: N
SELOX JT 45
MDR report key: 4240545
·
Received November 10, 2014
Report
- Report Number
- 1028232-2014-003994
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 28, 2014
- Report Date
- October 28, 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
THE LEAD HAS GREATER THEN 3200 OHM IMPEDANCE. (B)(4) 2014 - AS OF TODAY, ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS ACTIVELY IMPLANTED, BUT THE PLAN IS TO CAP THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724199 | SELOX JT 45 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 346369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |