BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3181977 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10702
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT SHOCKED WHEN HE PLUGGED A CORD INTO AN OUTLET. IT WAS NOTED THAT HE DID NOT KNOW THAT THERE WERE EXPOSED WIRES. IT WAS FURTHER NOTED THAT HE GOT A BURN ON HIS HAND. IT WAS NOTED THAT WHEN THE PATIENT GOT HOME HE CHECKED HIS UNIT AND IT WAS SO LOW HE HAD TO RECHARGE IT. IT WAS FURTHER NOTED THAT HE CHARGED FOR 8 HOURS AND ¿IT ONLY TOOK ½ THE CHARGE.¿ IT WAS NOTED THAT IT DIDN¿T FEEL LIKE THE SAME STIMULATION OR PULSE. IT WAS FURTHER NOTED THAT IT WAS NOT MANAGING THE PAIN LIKE IT WAS AND ALMOST FELT ¿LIKE A TINY BIT PAINFUL.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT SHOCKED BY THE DEVICE. IT WAS NOTED THAT HE WAS SHOCKED BY AN ELECTRIC CART AT A GROCERY STORE. IT WAS NOTED THAT IMPEDANCES WERE IN NORMAL RANGE. IT WAS NOTED THAT AN X-RAY WAS TAKEN AND REVEALED THAT THE PATIENT¿S LEFT LEAD HAD MOVED DOWN 1 AND A HALF VERTEBRAL BODIES DUE TO THE FALL. IT WAS NOTED THAT REPROGRAMING WAS DONE TO MOVE STIMULATION BACK INTO THE PATIENTS LEFT SIDE. IT WAS FURTHER NOTED THAT THE DOCTOR WAS AWARE OF THE X-RAY AND THAT THE LEAD HAD MOVED BUT IT WAS UNKNOWN WHAT THE DOCTOR INTENDED TO DO ABOUT IT. IT WAS NOTED THAT THE PATIENT STATED THAT AFTER REPROGRAMING HE WAS¿ BETTER THAN HE WAS BEFORE HE CAME IN.¿ IT WAS NOTED THAT HIS BATTERY WAS EMPTY SO HE CHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SURGED THE PATIENT'S SPINE AND CUT OFF. WHEN THE SHOCK OCCURRED THE PATIENT HAD ALMOST HALF A CHARGE AND WHEN THEY GOT HOME FROM THE HOSPITAL IT WAS SHOWING DEAD. IT WAS REPORTED THAT AFTER THE SHOCK THE PATIENT'S DEVICE JUST CUTS OFF AND DOESN'T FEEL LIKE THE SAME THING THEY HAD BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283411 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1