BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173234 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10404
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS DEVICE IDENTIFIED NO ANOMALIES. THIS SETSCREWS WERE REMOVED AND BOTH THE SETSCREW AND ASSOCIATED CONNECTOR BLOCK WERE MICROSCOPICALLY EXAMINED. THE SETSCREWS WERE CONFIRMED TO EXHIBIT SLIGHT SIGNS OF CROSS-THREADING, PARTICULARLY ON THE VENTRICULAR RING SETSCREW. THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED PER AUTOMATED TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED AT THE SAME TIME AS THE RIGHT VENTRICULAR LEAD WAS BEING REVISED. THE LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND IMPEDANCES OF GREATER THAN 2500 OHMS, AS A RESULT IT WAS REVISED. UPON PLACING THE LEAD INTO THIS PREVIOUS DEVICE THOSE ISSUES STILL REMAINED. THE PHYSICIAN BELIEVED THE LOC AND HIGH IMPEDANCES TO BE A DEVICE ISSUE. A NEW DEVICE WAS IMPLANTED AND THE LEAD WAS CONNECTED TO THE NEW DEVICE AND ALL ISSUES WENT AWAY. THE NEW DEVICE REMAINS IMPLANTED AND TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention S606| MISMATCH