BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3970353 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13737
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 8, 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
    MO, 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 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING ISSUES WITH STIMULATION COVERAGE SINCE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REVISION AND THEY HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT FELT TINGLING FROM THEIR KNEE DOWN AND FROM THEIR HIP TO THEIR STOMACH AND ALMOST BREAST AREA. IT WAS NOTED THE PATIENT WAS NOT FEELING STIMULATION IN THEIR THIGH WHERE THEIR PAIN WAS. THE REPORTER STATED THEIR PAIN WAS ON THEIR LEFT SIDE. THE REPORTER FURTHER STATED THAT THIS STARTED ON (B)(6) 2014. IT WAS NOTED THAT WHEN THE PATIENT SITS OR LIES DOWN IT¿S A PROBLEM, BUT IF THEY GOT UP AND EXERCISED OR WALKED THEY FELT STIMULATION HARD AND FAST. THE REPORTER STATED THAT STIMULATION WAS BETTER AT THAT TIME. THE REPORTER FURTHER STATED THEY INCREASED STIMULATION WITH THEIR PATIENT PROGRAMMER, BUT THE STIMULATION ENDS UP BECOMING TOO UNCOMFORTABLE IN THE OTHER AREAS WHERE THEY FELT STIM. IT WAS NOTED THE PATIENT STILL HAD PAIN IN THEIR THIGH. IT WAS FURTHER NOTED THE PATIENT WANTED TO WAIT AND TALK TO THE MANUFACTURER BEFORE ADJUSTING ANYTHING ELSE. IT WAS NOTED THE PATIENT STATED THAT SINCE THE REVISION, STIMULATION WAS TOO HIGH. IT WAS FURTHER NOTED THE PATIENT WAS FEELING STIMULATION IN JUST THE HIP AT 2.95V ON GROUP B. IT WAS NOTED THE PATIENT FELT STIMULATION IN THE OPPOSITE LEG ON GROUP C. IT WAS FURTHER NOTED THAT STIMULATION WAS GOING INTO THE BAD PART OF THEIR LEG THAT NEEDS THE STIMULATION, BUT IT WAS NOT ENOUGH ON GROUP D. THE REPORTER STATED THEY FELT STIMULATION IN THE LEFT HIP, A LITTLE IN THE LEFT THIGH, AND THEIR RIGHT FOOT ON GROUP G. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS NOT GETTING THE TINGLING IN THEIR THIGH WHERE THEY NEEDED IT AND IT WAS ¿ALL OVER THE PLACE.¿ IT WAS NOTED THAT IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. IT WAS FURTHER NOTED THE PATIENT WAS REPROGRAMMED WITH NEW GROUPS B AND C. THE REPORTER STATED THAT GROUP C HAD SOME POSITIONS WHICH USE PROGRAM ONE AND SOME WHICH USE JUST PROGRAM TWO. THE REPORTER FURTHER STATED THE PATIENT HAD BEEN ADVISED TO AVOID ANY ZERO AMPLITUDE SETTINGS. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. IT WAS FURTHER NOTED THE PATIENT WAS FEELING MUCH BETTER AND THEIR COVERAGE WAS VERY GOOD. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS INADEQUATE PROGRAMMING. IT WAS NOTED THE PATIENT WAS REPROGRAMMED FOR BETTER COVERAGE. THE REPORTER STATED THAT SEVERAL DIFFERENT COMBINATIONS OF PROGRAMMING WERE TRIED UNTIL SATISFACTORY COVERAGE WAS REACHED. IT WAS NOTED THAT IMPEDANCE TESTING WAS DONE AND ALL IMPEDANCES WERE WITHIN NORMAL LIMIT. IT WAS FURTHER NOTED THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION AND THEY WERE DOING WELL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448012 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR