SELOX ST 53
Report
- Report Number
- 1028232-2010-02634
- Event Type
- Other
- Date Received
- November 24, 2010
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- 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
TYPE OF REPORTABLE EVENT: DISLODGEMENT WITH SCHEDULED INTERVENTION.
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. ADDITIONAL INFORMATION: OUR LOCAL REPRESENTATIVE WAS CONTACTED ON 11/23/2010 IN REGARDS TO THE DISPOSITION OF THIS LEAD. WE WERE INFORMED THAT A LEAD REVISION WAS SCHEDULED FOR THAT DAY.
(B)(6) 2015: THIS LEAD WAS CAPPED DURING A DEVICE UPGRADE TO AN ICD ON (B)(6) 2013. THIS LEAD IS NO LONGER ACTIVE.
THE LEAD IMPEDANCE FELL FROM 1000 OHMS AT IMPLANT TO 400 OHMS ABOUT ONE MONTH POST IMPLANT. THE SENSING ON THE LEAD IS UNAFFECTED AND THERE IS NO CAPTURE. THE CHEST X-RAY SHOWS NO ABNORMALITIES. A LEAD REVISION PROCEDURE IS SCHEDULED FOR (B)(6) 2010. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 53 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 346366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| O |