BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1872379 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07812
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Report Date
    September 14, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT'S STIMULATION WAS FINE EXCEPT WHEN SHE WAS IN HER APARTMENT. STIMULATION WAS NOTED TO BE IN THE RIGHT PLACE AND AT THE RIGHT LEVEL, HOWEVER, SHE COULD FEEL PAIN "IN THE STIMULATION AREA" WHEN SHE WAS AT HOME. AS STIMULATION WAS INCREASED, THE PT WOULD FEEL MORE PAIN. THE PT NOTED WHEN STIMULATION IS TURNED OFF, SHE DOES NOT FEEL PAIN. THE PT BELIEVED THAT SOMEONE LIVING WITH/NEAR HER WAS CHANGING HER DEVICE PROGRAM, OR SENDING AN INTERFERING SIGNAL. ON (B)(6) 2010, THE PT WAS HAVING AN ISSUE WITH RECHARGING. REPOSITIONING THE ANTENNA AND RE-INITIATING CHARGING WAS DISCUSSED. THE PT WAS LATER ABLE TO GET ALL BLACK BARS FILLED IN BY MOVING THE ANTENNA DOWNWARD. ON 09/14/2010, IT WAS FURTHER REPORTED THAT EVERY TIME THE PT WENT HOME FOLLOWING DEVICE REPROGRAMMING, SHE WOULD LOSE HER PROGRAMS AND HAD TO GO BACK FOR REPROGRAMMING AGAIN. THE PT WASN'T SURE IF THE ISSUE WAS RELATED TO HER BEING IN HER APARTMENT, OR THE PT PROGRAMMER. IT WAS NOTED THAT THE ISSUE DID NOT OCCUR WITH THE PT'S OLDER/PREVIOUS DEVICE. THE PT'S STATUS WAS FAIR. REQUESTING A NEW PT PROGRAMMER WAS DISCUSSED. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    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 64 YR LOT # NFE139827H| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE151957N| EXPLANTED:| LEAD: MODEL 3487A, LOT # J0424776V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA113816N| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427,| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT # J0424776V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU052762V| EXTENSION: MODEL 7489, LOT # NHU052761V| EXPLANTED:| EXPLANTED: