BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 60/16

    MDR report key: 1933796 · Received December 13, 2010

    Report

    Report Number
    1028232-2010-02696
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SHOCK IMPEDANCE WAS 47 OHMS AT IMPLANT AND THE NEXT DAY IT WAS 110 OHMS. DAYS LATER, THE SHOCK IMPEDANCE IS GREATER THAN 150 OHMS. THEY ARE GOING TO SEE THE PT ON (B)(4) IN OFFICE AND DECIDE WHAT COURSE OF ACTION WILL BE TAKEN. ON (B)(4)2010 - WE WERE INFORMED THAT A LEAD REVISION WAS PERFORMED ON (B)(4) 2010 AND THE SET SCREW WAS TIGHTENED. THIS LEAD REMAINS IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG. 363303

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization