BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2913192 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16852
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION NOTED THE INSULATION WAS TORN AROUND THE CIRCUMFERENCE AND THE HIGH VOLTAGE CABLE WAS FRACTURED 21MM FROM THE TERMINAL PIN, WHICH WAS THE LOCATION WHERE THE TERMINAL PIN WOULD EXIT THE HEADER PORT. AS A RESULT, THE CLINICAL OBSERVATION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE WAS PROGRAMMED TO MONITOR ONLY AS THERE WERE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. AS A CONNECTION ISSUE BETWEEN THE ADAPTER AND LEAD WAS SUSPECTED, A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING THE PROCEDURE, THE SUTURE WAS NOT CONNECTED TO THE MUSCLE TISSUE. THE DEVICE HAD MOVED DOWNWARD TO THE LOWER PART OF THE ABDOMEN. THE CONNECTIONS WERE TIGHT THROUGH THIS AND ALL THREE ADAPTERS HAD INSULATON DAMAGE WHERE THE HEADER ENDS. IT WAS SUSPECTED THAT THE CHANGE OF DEVICE POSITION CREATED TOO MUCH TENSION ON THE ADAPTERS. AS NO DEVICE MALFUNCTION WAS SUSPECTED AND THERE WAS SUFFICIENT LONGEVITY, THE DEVICE REMAINS IMPLANTED WITH A NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20652 UNKNOWN IMPLANTABLE LEAD DTD CPI - DEL CARIBE 6931

    Patients

    Seq Age Sex Outcome Treatment
    1