BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 2170364 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09829
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RATE SENSING PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND REMAINS IMPLANTED AS THE SHOCKING PORTION OF THE LEAD IS STILL BEING USED. 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 DEVICE REPLACEMENT PROCEDURE OF ANOTHER MANUFACTURER'S DEVICE, THE TERMINAL PIN OF THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD BECAME SEPARATED FROM THE INSULATION. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT RECOMMENDED THE LEAD BE REPLACED. THE PHYSICIAN ELECTED TO SURGICALLY ABANDON THE RATE SENSING PORTION OF THE LEAD AND IMPLANTED A NEW RATE SENSING LEAD. THE PATIENT'S LEFT SIDE WAS OCCLUDED SO THE NEW RV LEAD WAS TUNNELED FROM THE RIGHT SIDE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 86 YR Life Threatening| R 4403| 1810| 0125| H135| 4269| 4513