BEUDAMED
    FDA Adverse Event Death Summary report: N

    SETROX S 53

    MDR report key: 3462041 · Received November 12, 2013

    Report

    Report Number
    1028232-2013-03362
    Event Type
    Death
    Date Received
    November 12, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 31, 2013
    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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED. THE MORPHOLOGY OF THE CUTTINGS INDICATES THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANT PROCEDURE. THE RETURNED LEAD FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYSED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD WAS, APART FROM THE PRESENT CUTTINGS WHICH MOST LIKELY RESULTED FROM THE EXPLANT PROCEDURE, FREE OF INSULATION BREACHES. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED AND PROVED TO BE FLAWLESS. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS PATIENT EXPIRED ON 10/23/2013. THIS DEVICE WAS EXPLANTED ON (B)(6) 2013. ADDITIONAL INFORMATION WAS OBTAINED INFORMING US THIS PATIENT RECEIVED 9 SHOCKS AT THE TIME OF DEATH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583983 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death