BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2050178 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02515
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT IMPLANT, THE SURGEON ATTEMPTED TO CONNECT THE LEADS TO THE INS. HE WAS UNABLE TO PASS THE LEAD THROUGH THE BOTTOM HOLE (CONNECTIONS 8-15) OF THE INS EVEN WITH THE SCREW AS LOOSE AS POSSIBLE. HE ATTEMPTED MULTIPLE TIMES WITHOUT SUCCESS. THE TORQUE SCREW COULD NOT PASS THROUGH EITHER. THE LEAD WAS BEGINNING TO BE DAMAGED, SO A DIFFERENT INS WAS ATTEMPTED AND THE LEADS PASSED THROUGH WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR