BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1954161 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24475
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 DEVICE CHANGE OUT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD PULLED APART BETWEEN THE TERMINAL PIN AND THE RING WHEN THE PHYSICIAN PERFORMED A TUG TEST. THE IS-1 PACE\SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. 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 70 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)