BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE T165/141337 IMPLANTED 07-MAR-2008

    MDR report key: 1534777 · Received November 10, 2009

    Report

    Report Number
    2124215-2009-14957
    Event Type
    Malfunction
    Date Received
    November 10, 2009
    Date of Event
    July 1, 2009
    Report Date
    December 6, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED PROXIMAL PORTION OF THE LEAD WAS PERFORMED. THE LEAD WAS SEVERED 11.8 CENTIMETERS FROM THE TERMINAL PIN. RESISTANCE TESTING VERIFIED THAT THE LEAD SEGMENT WAS ELECTRICALLY CONTINUOUS. LABORATORY TESTING WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT YEARS LATER A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS FROM ANOTHER MANUFACTURER. THE LEAD WAS CONNECTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE T165/141337 IMPLANTED 07-MAR-2008 IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR