BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 2974001 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00285
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    October 26, 2012
    Report Date
    January 31, 2013
    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

    THE ANALYSIS OF THE SETROX S 45 LEAD DEMONSTRATED MULTIPLE SIGNS OF ABRASION. IN THE PROXIMAL PART OF THE LEAD, THE INSULATION WAS FOUND RUBBED THROUGH. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. AN INTERACTION BETWEEN THE LEAD AND THE ICD HOUSING SHOULD BE TAKEN INTO CONSIDERATION. THE LEAD'S DISTAL PART WAS FOUND PARTLY PULLED OUT FROM THE RING ELECTRODE AND CUTTINGS IN THE INSULATION WERE FOUND AT THE LEAD BODY WHICH RESULTED MOST LIKELY FROM THE EXPLANT PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS PROGRAMMED OFF IN (B)(6) 2008, THE EXACT DATE IS UNKNOWN, DUE TO EXIT BLOCK. THIS LEAD WAS CAPPED ON (B)(6) 2012 DURING A NORMAL DEVICE CHANGE OUT. THIS LEAD WAS EXPLANTED ON (B)(6) 2013. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64274 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization