BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 2915508 · Received January 9, 2013

    Report

    Report Number
    1028232-2013-00018
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE VISUAL ANALYSIS DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS PULLED OUT OF THE RING ELECTRODE. BLOOD PENETRATED THE LEAD. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. THE CUTTINGS OF THE INSULATION AND THE DEFORMATION OF THE FIXATION HELIX RESULTED MOST LIKELY FROM THE EXPLANT PROCEDURE. DURING ANALYSIS, NO FURTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT WHILE UPGRADING THE PATIENT TO A CRT-P. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10617 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization