BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 2170823 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10032
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, FIRM PRESSURE WAS REQUIRED BY THE PHYSICIAN TO REMOVE THIS RIGHT VENTRICULAR (RV) LEAD FROM THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AFTER THE LEAD WAS REMOVED FROM THE HEADER, THE INSULATION WAS OBSERVED TO HAVE SEPARATED FROM THE TERMINAL PIN. THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW ICD AND RV LEAD WERE IMPLANTED SUCCESSFULLY WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)