BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3870534 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11514
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿IT SHUT OFF BY ITSELF.¿ IT WAS NOTED THAT THE PATIENT FELT LIKE THE STIMULATION SHUT OFF. THE PATIENT STATED THAT ¿IT WAS SHUTTING OFF BY ITSELF¿ WHEN THEY WERE SITTING AND ALSO WHEN THEY WERE WALKING. THE PATIENT STATED THAT THE NIGHT PRIOR TO REPORT THEY WERE WALKING AND ¿IT FELT LIKE IT SHUT OFF FOR OVER AN HOUR.¿ THE PATIENT WAS WALKING BACK FROM THE LOCATION THAT THEY WERE AT AND ¿IT FELT LIKE IT TURNED ON.¿ THE PATIENT NOTED THAT THEY HAD THREE SETTINGS WITH WHICH THEY WERE PROGRAMMED AND ASKED ¿IF THAT MADE ANY DIFFERENCE.¿ IT WAS NOTED THAT THE SETTINGS WERE FOR LAYING DOWN, SITTING AND STANDING. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY FALLS, TRAUMAS, MEDICAL PROCEDURES OR ¿ANYTHING.¿ PATIENT SERVICES ASKED THE PATIENT IF THEY WANTED TO CHECK THE SETTINGS TO SEE IF THEY CHANGE. THE PATIENT STATED THAT THE SITTING UPRIGHT WAS PROGRAM ONE AT 3.8V, PROGRAM TWO WAS 3.60V AND PROGRAM THREE WAS 3.10V. IT WAS NOTED THAT THE ¿SETTING ACTUALLY WAS A LOWER SETTING IN THE POSITION THEN THE UPRIGHT SETTINGS.¿ PATIENT SERVICES ASKED THE PATIENT IF THEY COULD START WALKING, IF MEDICALLY APPROPRIATE, AND OBSERVE IF THE SETTING WAS STILL THE SAME OR IF IT CHANGED. THE PATIENT STATED IT WAS 3.40V. THE PATIENT INCREASED IT UP TO 3.60 AND CONTINUED TO WALK FOR OVER THREE MINUTES TO CHANGE THE ADAPTIVE STIMULATION SETTING. THE PATIENT THEN SAT BACK DOWN, CHECKED THE SETTINGS AND NOTED THAT THE SETTING ¿TOOK.¿ IT WAS NOTED THAT THIS ACTION RESOLVED THE REPORTED ISSUE. THE PATIENT STATED THAT THE DEVICE WAS PRETTY NEW AND THEY HAD IT ¿ALMOST¿ THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347962 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR