BEUDAMED
    FDA Adverse Event Death Summary report: N

    SETROX S 53

    MDR report key: 1027773 · Received April 10, 2008

    Report

    Report Number
    1028232-2008-00360
    Event Type
    Death
    Date Received
    April 10, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE AT THE OUTER INSULATION OF BOTH LEADS IS PROBABLY DUE TO THE EXPLANTATION. THE DEFORMATION OF THE SHOCK COILS IS WITH HIGH PROBABILITY A RESULT OF EXCESSIVE TENSILE FORCES DURING THE EXPLANTATION. THE ANALYSIS WAS UNABLE TO FIND ANY MFG ERROR OR MATERIAL DEFECT.

    Description of Event or Problem · 1

    OUS MDR. IT WAS REPORTED THAT THE PT DIED IN THE NIGHT AFTER THE IMPLANTATION. THE ICD COULD BE INTERROGATED THE NEXT DAY AND WAS RETURNED, WITH THE LEADS TO BIOTRONIK FOR ANALYSIS. ALSO EXPLANTED: LUMAX 300 DR-T, MDR 1028232-2008-00358. LINOX SD 75/18, MDR 1028232-2008-00359.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 Death