BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 3241166 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-02091
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    February 16, 2013
    Report Date
    April 9, 2013
    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 PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, A MECHANICAL AND AN ELECTRICAL ANALYSIS. THE INSPECTION REVEALED A RUBBED THROUGH INSULATION AT APPROX. 45.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF AN INTERACTION BETWEEN THE LEAD BODY AND THE NEARBY LEAD. THE DEFORMATION OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN RESULTED MOST LIKELY DUE TO OVER-ROTATION OF THE INNER COIL. REGARDING THE HIGH THRESHOLDS MENTIONED IN THE COMPLAINT DESCRIPTION, NO DEVIATIONS WERE FOUND DURING ANALYSIS. IN PARTICULAR, THE MEASURED IMPEDANCE VALUES ARE WITHIN THE TECHNICAL SPECIFICATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO CHRONIC HIGH THRESHOLDS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340565 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization