BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1851833 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14300
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IS-1 RATE/SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND A NEW RATE/SENSE LEAD WAS IMPLANTED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE, WHEN THE RATE/SENSE PORTION OF THIS VENTRICULAR DEFIBRILLATION LEAD WAS REMOVED FROM THE HEADER OF THE DEVICE, THE LEAD PIN PULLED APART AND THE ELECTRODE WIRE UNCOILED. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    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 71 YR 1860| 0125| 1762