BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1851170 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07478
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 24, 2009
    Report Date
    May 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH RECHARGING. PATIENT WAS GETTING THE ANTENNA TOO HOT SCREEN WHEN CHARGING. RECOMMENDED STOPPING RECHARGE AND TRYING AGAIN. PATIENT STATED THAT SHE HAD A PERONEAL NERVE COMPRESSION IN (B)(6) 2009 AND HAD THE DEVICES MOVED IN (B)(6) 2009 AND THEN GOT INFECTED. THEN THEY WERE IMPLANTED IN HER THIGH ON HER LEFT LEG. SINCE THEN, SHE HAS HAD WEIGHT LOSS. THE DEVICES ARE ABOUT 2 1/2 CM APART. THE NERVE SURGERY WAS NOT RELATED TO THE DEVICE OR LEAD. THIS PATIENT HAD TWO OF THE FOUR LEADS REPOSITIONED FOR LEAD MIGRATION. SHE NOTICED STIMULATION CHANGES AFTER KIDNEY SURGERY. THE PATIENT WAS DIAGNOSED WITH RENAL CARCINOMA AND THE PAIN MD SUGGESTED THAT HER HEALING PROCESS MAY HAVE BEEN AFFECTED BY THAT. IT WAS NOT CERTAIN IF THE LEADS HAD MOVED DURING POSITIONING FOR SURGERY. THIS PATIENT HAD FOUR OCTAD LEADS IN HER LEFT FOOT AND SHE HAS HAD MULTIPLE FOOT SURGERIES LEADING TO CHRONIC FOOT AND ANKLE PAIN. THE PATIENT WAS TRYING TO RECHARGE BOTH DEVICES AT THE SAME TIME, SHE WAS INSTRUCTED TO CHARGE SEPARATELY. THE COMPANY REPRESENTATIVE HAD NOT HEARD OF ANY DIFFICULTY RECHARGING LATELY. THE HCP RESPONDED THAT IT WAS UNKNOWN IF THE EVENT WAS ATTRIBUTABLE TO THE DEVICE. THERE HAD BEEN A REVISION. THE DEVICE HEATED UP AND THEY DID NOT THINK IT WAS A PROBLEM ANYMORE. SHE WAS DOING FINE WITH THE REVISION. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2010-07479.

    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 39 YR Required Intervention EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE102964N| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| ACCESSORY: MODEL 37752, LOT# NKA111056N| IMPLANTED:| LEAD: MODEL 3777, LOT# V077844022| LEAD: MODEL 3777, LOT# V068654006| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NKF703829H| IMPLANTED:| LEAD: MODEL 3777, LOT# V106486002| IMPLANTED:| LEAD: MODEL 3777, LOT# V096193030| IMPLANTED:| EXPLANTED: