BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2061907 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02612
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    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
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT WAS EXPERIENCING COUPLING AND COMMUNICATION ISSUES. USE OF THE ANTENNA LOCATE FEATURE RESULTED IN A POWER ON RESET BEING DISPLAYED ON THE PATIENT RECHARGER SCREEN WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN AND RESOLVED THE ISSUE. THE PATIENT STATED HE HAD A LOSS OF THERAPEUTIC EFFECT WHICH WAS THE REASON HE WAS NOT USING THE INS ANYMORE. NO ACCIDENT OR INCIDENT WAS RELATED TO THE LOSS OF STIMULATION. PATIENT WAS TOLD HE MAY WANT TO CONSIDER REPROGRAMMING AS AN OPTION TO RE-ESTABLISH THERAPEUTIC STIMULATION.

    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 36 YR LEAD: MODEL 3777, LOT# V241889023| EXPLANTED:| LEAD: MODEL 377745, LOT# V010626| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE114369N| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA125224N| EXPLANTED:| LEAD: MODEL 377745, LOT# V001490