BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3210861 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08097
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. DURING EXTRACTION, THE LEAD WAS BROKEN. THE DISTAL PORTION WAS SURGICALLY ABANDONED IN THE PATIENT AND THE PROXIMAL PORTION WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311674 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0135

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R