BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELOX ST 53

    MDR report key: 5576272 · Received April 14, 2016

    Report

    Report Number
    1028232-2016-01526
    Event Type
    Death
    Date Received
    April 14, 2016
    Date of Event
    December 2, 2012
    Report Date
    February 15, 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

    ON 4/12/16 - BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THIS EVENT BE REPORTED TO THE FDA. THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. UPON RECEIPT, THE SELOX ST WAS FOUND HEAVILY ELONGATED. THE ANALYSIS OF THE SELOX ST LEAD REVEALED A RUBBED THROUGH INSULATION IN THE REGION OF THE TRICUSPID VALVE. 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. INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES OF THE LEAD 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 DEVICE WAS RETURNED WITH PARTIAL OOS DOCUMENTATION FROM MEDTRONIC, INC. PER OOS, THIS PATIENT EXPIRED ON (B)(6) 2012. THE FOLLOWING PHYSICIAN'S OFFICE HAS NO INFORMATION REGARDING THIS PATIENT'S DEATH. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. ON 4/12/16 - BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THIS EVENT BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234007 SELOX ST 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death