BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-21635

    MDR report key: 1894467 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21635
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 11, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM: UPDATE TO DECISION PATHWAY AS POTENTIAL FOR SERIOUS INJURY AS A RESULT OF SURGICAL INTERVENTION HAVING BEEN PERFORMED TO ADDRESS THIS PARTICULAR ISSUE. NO OTHER CHANGES OR ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE INVESTIGATION IS CONSIDERED RE-CLOSED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THE PACE/SENSE PORTION OF THE RV LEAD IS NO LONGER IN SERVICE. THIS DEVICE REMAINS IN SERVICE. THE INVESTIGATION OF THIS ISSUE REMAINS OPEN IN AN ATTEMPT TO COLLECT THE SPECIFIC ASSOCIATED MODEL/SERIAL INFORMATION FROM THE LOCAL AREA SALES REPRESENTATIVE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR (RV) IN ASSOCIATION WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID EXHIBIT GREATER THAN 2,000 OHMS PACE IMPEDANCE MEASUREMENT. THERE WAS ALSO LOSS OF CAPTURE BUT THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT BEYOND THE NEED FOR SURGICAL INTERVENTION, THE PATIENT EXPERIENCED NO HARM. SUBSEQUENT INFORMATION WAS RECEIVED OF THE REVISION PROCEDURE DONE THE FOLLOWING DAY. DURING THIS PROCEDURE, TWO SEPARATE RV LEADS WERE ATTEMPTED UNSUCCESSFULLY AND THE PROCEDURE WAS ULTIMATELY ABANDONED. THERE WERE NO ALLEGATIONS AGAINST THE ASSOCIATED DEVICE. THE PATIENT WAS GOING TO CONTINUE TO BE MONITORED BY THE PHYSICIAN.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1