BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 3021839 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00815
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2013. AT EXPLANT, THE RV COIL CONDUCTOR WAS FOUND TO BE COMPLETELY SEVERED PROXIMAL TO THE YOKE. THE LEAD REMAINS AT THE HOSPITAL. THE LEAD IMPEDANCE WAS MORE THAN 150 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124650 KENTROX SL-S 65/16 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 345988

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization