BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2175313 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04445
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S STIMULATION WAS INTERMITTENT DURING NORMAL MOVEMENT AND WHEN ARCHING HER BACK. SHE ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT NOTICED THAT HER BACK WAS ACHING MORE AND FELT A "PINCHING SENSATION" IN HER LOW BACK, LEGS, AT THE NEUROSTIMULATION LOCATION, AND AT THE LEAD LOCATION WHEN LYING DOWN OR RECHARGING. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V618843034| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V613607030| IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT #254640001| ACCESSORY: MODEL 37752, LOT # NKA149555N| PROGRAMMER: MODEL 37743, LOT # NKE159621N| EXPLANTED: