BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3181464 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10674
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 31, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TOOK A NAP AND BEFORE THE PATIENT COULD CHANGE SETTING ON THE IMPLANTABLE NEUROSTIMULATOR (INS) THE PATIENT GOT ¿SHOCKED, SO BADLY LIKE IT WAS UP IN THE UPPER LEFT HAND SIDE OF HER BACK WHERE THE LEADS ARE LOCATED. IT FELT LIKE THE ELECTRODES WERE SHORTING OUT IN HER BACK.¿ IT WAS NOTED THAT FOR 24 HOURS AFTER THE EVENT THE PATIENT FELT HEAT IN THAT AREA. THE PATIENT'S THE HEALTH CARE PROVIDER (HCP) TOLD PATIENT TO TURN INS OFF AND IT WAS NOTED THE HCP THOUGHT IT MIGHT BE A MUSCLE SPASM, BUT THE PATIENT DID NOT THINK SO. THE PATIENT KEPT HER INS OFF FOR 24 HOURS WHICH SEEMED TO HELP BUT THE PATIENT EXPERIENCED THE SAME THING THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT PATIENT HAD FELT A ¿HOT SPOT¿ IN THE BACK, LIKE PATIENT¿S ¿MUSCLE HAD ACTUALLY BEEN FRIED, IT WAS SO PAINFUL.¿ IT WAS REPORTED THAT IT WAS ACTUALLY HOT TO TOUCH. IT WAS REPORTED THAT AFTER 24 HOURS PATIENT TURNED THE IMPLANT BACK ON AND ¿EVERYTHING SEEMED FINE SINCE THEN UNTIL DAY OF REPORT AROUND 4PM. IT WAS REPORTED THAT THE SAME THING HAPPENED, AND IT HURT ¿SO BAD.¿ IT WAS REPORTED THAT THE PATIENT FELT LIKE THE SKIN/MUSCLE WAS BEING ¿BURNT.¿ PATIENT REPORTED THAT THESE EVENTS FELT MORE LIKE A REALLY INTENSE BURNING SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281868 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