BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2101719 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03436
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    REC'D INFO DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO SECURE THE LEAD INTO THE IMPLANTABLE NEURO STIMULATOR. THE SCREW WHICH CLOSES AND SECURES THE LEAD INTO THE DEVICE FAILED TO TIGHTEN SUFFICIENTLY. DESPITE NUMEROUS ATTEMPTS TO SECURE THE LEAD IN THE DEVICE, THE SCREW WOULD NOT TIGHTEN ONTO THE LEAD. A SECOND INS WAS OPENED AND SECURED SUCCESSFULLY ON FIRST ATTEMPT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0317771

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR