BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1940643 · Received December 17, 2010

    Report

    Report Number
    3004209178-2010-10566
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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

    INFORMATION RECEIVED REPORTS THE INS WAS OVERDISCHARGED AND SHOWING A POWER ON RESET CONDITION. THE PATIENT STATES SHE RECHARGED TO 75% THE NIGHT BEFORE. MEDTRONIC REPRESENTATIVE WORKING WITH THE PATIENT TO RECHARGE DEVICE ENOUGH TO CLEAR THE POWER ON RESET. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT FEELS SHE IS RECHARGING MORE THAN EXPECTED. ALSO FOR THE PAST YEAR, WHILE STIMULATION IS TURNED ON, THERE IS PAIN IN THE POCKET AREA AND STABBING PAINS IN THE BACK AREA WHERE THE LEADS ARE LOCATED. THE PAIN IS CONSTANT. PATIENT HAS HAD SEVERAL FALLS WITHIN THE PAST YEAR. MEDTRONIC REPRESENTATIVE STATES PALPATING THE AREA CAUSES STIMULATION CHANGES. IMPEDANCES ARE WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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 17 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V138927021| EXPLANTED:| LEAD: MODEL 3778, LOT# V138927020| PROGRAMMER: MODEL 37743, LOT# NKE116915N