BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4040216 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-15963
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    August 4, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# V000795, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD RECENTLY BEEN SEEN AT THE OFFICE AND WAS SEEN BY A MANUFACTURER'S REPRESENTATIVE TO TROUBLESHOOT THE CURRENT SYSTEM, BUT THE PATIENT LEFT ABRUPTLY AND "WAS VERY UNHAPPY." IT WAS STATED THAT THE PATIENT "SOUNDED AGITATED" BUT THE CALLER HAD NO INFORMATION ABOUT WHAT CONDITION THE PATIENT WAS IN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN IN HER LEGS WITH STIMULATION ON. THE PATIENT SHUT STIMULATION OFF AND THE PAIN GOT BETTER. THE PATIENT STILL HAD A LOT OF PAIN ALL OVER HER BODY. IT WAS NOTED THAT THIS HAD STARTED SUDDENLY. THERE WERE NO FALLS OR TRAUMAS AROUND THE TIME THE ISSUE HAD STARTED. THE PAIN WITH STIMULATION ON HAD STARTED ON THE MORNING OF THE DATE OF THIS REPORT. IT WAS LATER REPORTED THE PATIENT HAD WOKEN UP ON THE (B)(6) 2014 WITH PAIN IN HER LEGS AND THE PAIN HAD INCREASED AS THE DAY HAD GONE ON. BY NOON, THE PATIENT¿S LEGS WERE SHAKING AND BOUNCING UP AND DOWN. THE PATIENT WAS IN HORRIBLE/UNBEARABLE PAIN. THE PATIENT HAD GONE TO THE HOSPITAL. PATIENT HAD GOTTEN ALMOST IMMEDIATE RELIEF WHEN STIMULATION WAS TURNED OFF AND HER LEGS STOPPED JUMPING AROUND. PATIENT HAD AN APPOINTMENT WITH HER HEALTHCARE PROFESSIONAL ON (B)(6) FOLLOWING THE DATE OF THIS REPORT. THE PATIENT WAS IN AN INTENSIVE CARE/OBSERVATION ROOM AT THE HOSPITAL AT THE TIME OF THIS REPORT. IT WAS LATER REPORTED THAT THERE WAS OVERSTIMULATION AND A SHOCKING/JOLTING SENSATION. ON THE EVENING OF (B)(6) 2014, THE PATIENT HAD BEEN WALKING DOWN THE HALL AT THEIR HOME AND EXPERIENCED A JOLTING/SHOCKING STIMULATION DOWN BOTH LEGS AND IT HAD LEFT HER LEGS FEELING NUMB AND PARALYZED. STIMULATION HAD BEEN ON AT THAT TIME. TREMBLING AND PAIN SEVERITY HAD LED HER TO EMERGENCY ROOM. PAIN AND TREMBLING HAD SUBSIDED WHEN STIMULATION WAS TURNED OFF WHILE IN THE EMERGENCY ROOM. THE PATIENT¿S BLOOD WORK AND COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE TAKEN AND NOTHING HAD RESULTED FROM THOSE TESTS. THE PATIENT HAD THE DEVICE OFF SINCE THEN. ON (B)(6) 2014, IMPEDANCES WERE CHECKED AND WERE WITHIN NORMAL LIMITS. THE SENSATION THAT THE PATIENT HAD FELT ON (B)(6) COULD NOT BE REPLICATED. THE PATIENT WAS NOT ABLE TO PROFICIENTLY DEMONSTRATE PROPER USE OF THE PROGRAMMER, TURNING ON/OFF AND INCREASING/DECREASING INTENSITY. ADDITIONAL TEACHING ON OPERATING THE PROGRAMMER WAS OFFERED. PATIENT WAS INFORMED THAT SHE WOULD HAVE TO ADJUST INTENSITY ACCORDING TO HER COMFORT AND BODY POSITION. A COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN WAS ORDERED ON (B)(6) 2014 TO INVESTIGATE FURTHER. THE PATIENT HAD LEFT ON (B)(6) 2014 WITH THE DEVICE TURNED OFF. THE PATIENT WAS ALIVE WITH NO INJURY. PATIENT HAD PAIN IN BILATERAL LOWER EXTREMITIES. ADDITIONAL INFORMATION RECEIVED REPORTED ON AUGUST 20TH 2014, THE PATIENT HAD BEEN GIVEN A PRESCRIPTION FOR CT AND HAD NOT GONE FOR THE CT SCAN. WHEN STIMULATION WAS TURNED ON THE PATIENT WAS FEELING STIMULATION IN THE LOW BACK AND DOWN BOTH LEGS WHICH WAS WHERE SHE HAD TYPICALLY HAD PAIN. THE PATIENT WAS NOT ABLE TO DEMONSTRATE EFFECTIVELY ON HOW TO OPERATE THE PATIENT PROGRAMMER. THE PATIENT WAS UNWILLING TO LEARN AND WANTED TO LEAVE. IT WAS UNKNOWN IF STIMULATION HAD BEEN TURNED BACK ON. THE MANUFACTURING REPRESENTATIVE HAD CALLED THE PATIENT ON (B)(6) 2014 AND HAD NOT HEARD BACK FROM THE PATIENT AND NEITHER HAD THE HEALTHCARE PROFESSIONAL¿S OFFICE. IT WAS NOTED THAT THE PATIENT HAD PRESENTED TO ANOTHER HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519557 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| O