BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3418417 · Received October 18, 2013

    Report

    Report Number
    3004209178-2013-19330
    Event Type
    Malfunction
    Date Received
    October 18, 2013
    Report Date
    September 25, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37083-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37083-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # V113343, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ¿VERY, VERY LARGE¿ BLACK AND BLUE MARK BELOW WHERE THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON HIS HIP AND ¿THE THING THEY PUT UP HIS BACK.¿ IT WAS NOTED THAT THE MARK WAS VERY LARGE, ¿BIGGER THAN A FIST.¿ IT WAS REPORTED THAT THE PATIENT COULDN¿T LIE DOWN AT NIGHT AT ALL BECAUSE OF THE PAIN IN THE PATIENT¿S LEG. THE REPORTER STATED THAT THE PATIENT SHOULDN¿T BE IN PAIN BECAUSE HE HAD THE INS AND PATIENT PROGRAMMER TO TURN IT UP OR DOWN. IT WAS REPORTED THAT THE PATIENT COULD ¿WALK AROUND SOME¿ BUT IT WAS VERY PAINFUL. IT WAS NOTED THAT THIS STARTED A COUPLE OF WEEKS PRIOR TO THE REPORT AND THE PATIENT WAS IN SO MUCH PAIN THAT THEY DIDN¿T KNOW WHAT TO DO ABOUT IT OR WHAT WAS WRONG WITH HIM. IT WAS REPORTED THAT THERE WAS NO KNOW ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE REPORTER STATED THAT IT WAS UNKNOWN IF THE INS OR PATIENT PROGRAMMER WAS CAUSING THE ISSUE. IT WAS LATER REPORTED THAT THE PATIENT HAD PAIN AT THE LEFT HIP BELOW THE INS. TWO WEEKS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT WALKED THROUGH A METAL DETECTOR AND THE EVENT WAS ATTRIBUTED TO THE INS. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(4) 2013 AND THE PROGRAMMER WAS RESET TO THE ORIGINAL SETTINGS. IT WAS REPORTED THAT THE PATIENT WAS VERY PLEASED AND FELT HE WAS GETTING GOOD COVERAGE AND CIRCULATION. SIGNS AND SYMPTOMS OF THE EVENT INCLUDED THAT THE SPINAL CORD STIMULATION WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY AND NON-SERIOUS ILLNESS/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536412 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR