BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1950386 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22325
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 21, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    Z-1144/1145-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DAMAGE WAS ON THE IS-1 PORTION OF THIS LEAD, THIS PORTION WAS CAPPED SO THAT THE LEAD COULD REMAIN IMPLANTED FOR DEFIBRILLATION PURPOSES. A NEW PACE/SENSE LEAD WAS THEN SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE REPLACEMENT, IT WAS DISCOVERED THAT THE INSULATION ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS DAMAGED CLOSE TO THE CONNECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0125| T175| 4097| 1763