BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 3010559 · Received March 19, 2013

    Report

    Report Number
    1028232-2013-00722
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 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

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED A DEFORMED FIXATION HELIX. DAMAGING THE FIXATION HELIX REQUIRES THE PRESENCE OF MECHANICAL STRESS. MECHANICAL STRESS DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. IN ADDITION, DEFORMATIONS OF THE OUTER COIL AND CUTTINGS IN THE INSULATION WERE FOUND. THEY RESULTED MOST LIKELY FROM THE EXPLANT PROCEDURE. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, A DEFORMED FIXATION HELIX WAS NOTED ON THE RETURNED LEAD COMPROMISING THE PERFORMANCE OF THE ACTIVE FIXATION MECHANISM. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED ONE DAY POST IMPLANT DUE TO INTERMITTENT OUTPUT. THE PHYSICIAN CHOSE TO EXPLANT THIS LEAD AND REPLACE IT, BECAUSE THERE WAS TISSUE IN THE HELIX. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114192 SETROX S 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization