BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1342005 · Received March 3, 2009

    Report

    Report Number
    2124215-2009-04282
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    November 10, 2007
    Report Date
    March 4, 2009
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER GUIDANT IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF MORE INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION, THAT DURING THE ATTEMPTED IMPLANT OF THIS IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD, THE LEAD NOT FIT WITH THE CRT-D DF-1 PORT. THE PHYSICIAN TRIED TO FIT AN IS-1 LEAD AND AN IS-1 PLUG, WHICH WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS GUIDANT CORPORATION 0185

    Patients

    Seq Age Sex Outcome Treatment
    1