BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2042445 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01816
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACING SYSTEM IS SCHEDULED TO BE EXTRACTED DUE TO A PATIENT INFECTION. IT WAS NOTED THAT ONE OF THE LEAD'S HAD BROKEN IN HALF AND REMAINS IN THE PATIENT. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT ON A VENTILATOR. THE PHYSICIAN WILL ATTEMPT TO GO BACK IN TO REMOVE THE REST OF THE PACING SYSTEM WITHIN THE NEXT WEEK.

    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 45 YR Hospitalization| L| R 1820| 1861| E110| 4269| 0125