BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNCTUA

    MDR report key: 3951146 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14262
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S DEVICE WAS EVALUATED; HOWEVER, NO CAUSE WAS CONCLUSIVELY DETERMINED. THE PATIENT WILL BE MONITORED THROUGH ROUTINE FOLLOW-UP. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427987 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N051

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4542| 4135| K063| N051| 4136| 0180