BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 4132352 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14601
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ONE WEEK POST-IMPLANT FOLLOW-UP, HIGH OUT OF RANGE PACING IMPEDANCE, ALONG WITH HIGH PACING THRESHOLDS, WERE EXHIBITED WITH THIS LEFT VENTRICULAR LEAD SYSTEM. ALTHOUGH NO X-RAY WAS TAKEN TO CONFIRM ROOT CAUSE, THE PHYSICIAN SUSPECTED THE LEAD HAS DISLODGED. NO INTERVENTION IS PLANNED AT THIS TIME AND NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612699 AUTOGEN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 4671| 7741| G179| 0695