BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3011570 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03942
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION SENSATION WAS FADING FOLLOWING A FALL WHERE THEY SLIPPED THE MONTH PRIOR TO REPORT. IT WAS STATED THAT THE PATIENT HAD 5-6 EPISODES THAT BEGAN ABOUT TWO WEEKS PRIOR TO REPORT. IT WAS ALSO STATED THAT THE PATIENT'S SYMPTOMS WERE IN THE "AREA OF PARESTHESIA". THE CALLER STATED THAT THE PATIENT'S STIMULATION "DIMMING" WAS NOT PAINFUL "JUST NOTICEABLE AND OVERALL THE PATIENT WAS GETTING GOOD THERAPY" BUT THE PATIENT COULDN'T PINPOINT ANY SPECIFIC POSITION THAT SHE WAS TAKING WHEN FADING OCCURRED. IT WAS ALSO NOTED THAT THE "FADING SENSATION HAPPENED AND WAS OVER SO QUICKLY" THAT SHE WAS UNABLE TO USE HER PROGRAMMER TO IDENTIFY THE POSITION OF THE IMPLANTABLE NEUROSTIMULATOR. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT IMPEDANCES WERE CHECKED AND NORMAL IN TWO DIFFERENT POSITIONS, STANDING AND LEANING FORWARD. ADAPTIVE STIMULATION WAS TURNED OFF AND THE PATIENT HADN¿T HAD ANY FURTHER ISSUES. HOWEVER, THE PATIENT REPORTEDLY TURNED ADAPTIVE STIMULATION BACK ON AFTER A FEW DAYS OF TRIALING WITH IT OFF. THE PATIENT DECIDED THAT SINCE THE FADING WASN¿T PAINFUL, SHE WAS JUST GOING TO LIVE WITH IT, SO SHE COULD GET THE BENEFIT OF ADAPTIVE STIMULATION. THE REPORTER INDICATED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114449 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1