BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4192857 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20166
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    February 3, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377760, LOT# V004734, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# V003918, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EXPERIENCING A SURGING SENSATION AND THE PATIENT STATED ¿I¿VE HAD IT N INE YEARS AND I AM GETTING IT REPLACED THURSDAY AND I WANTED TO KNOW IF I NEEDED TO BRING THE CHARGER AND THE CONTROLLER WITH?¿ THE PATIENT STATED THAT HER IMPLANTABLE NEUROSTIMULATOR (INS) ¿WAS SURGING AND THE MANUFACTURER¿S REPRESENTATIVE (REP) SAID IT WAS READY TO BE CHANGED.¿ THE SURGING STARTED ¿ABOUT THREE MONTHS AGO, AND IT HADN¿T BEEN SURGING THE WHOLE TIME BUT WHEN IT SURGED IT SCARED ME.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING SURGING ON HER LEFT SIDE. THE PATIENT SAID THE SURGING STARTED ON (B)(6) 2014. THE PATIENT HAD NO FALLS OR TRAUMAS, THE SURGING CAME ON SUDDENLY. THE AMPLITUDE WAS DECREASED AND THE SURGING DECREASED BUT SHE WAS STILL FEELING IT. THE SURGING DID NOT HURT BUT SHE COULD STILL FEEL IT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS (B)(6) OR GREATER SYMPTOMS REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS DEVICE RELATED. REPROGRAMMING WAS NEEDED. THERE WAS AN END OF LIFE FOR STIMULATOR, THE PATIENT WAS TO BE SCHEDULED FOR GENERATOR REPLACEMENT ON (B)(6) 2014. THE PATIENT EXPERIENCED A SUDDEN LOSS OF THERAPEUTIC EFFECT. THE PATIENT DID NOT EXPERIENCE A LOSS OF STIMULATION. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673531 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention