BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2153436 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04638
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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). THE NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER THE LEAD WAS CONNECTED TO THE NEUROSTIMULATOR AT IMPLANTATION, THE SCREWS WERE TIGHTENED AND AN IMPEDANCE CHECK INDICATED AN OPEN CIRCUIT (HIGH IMPEDANCES). THIS WAS REPEATED FIVE TIMES. THE LEADS WERE THEN CONNECTED TO A SNAP-LID CONNECTOR AND THE NEUROSTIMULATOR. IMPEDANCE READINGS WERE THEN, NORMAL. A SECOND NEUROSTIMULATOR WAS OPENED AND CONNECTED TO THE LEAD. NORMAL IMPEDANCE VALUES WERE SEEN.

    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 79 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V651973020