BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORESENSOR MRI

    MDR report key: 4121241 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17788
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    August 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 355531, LOT# N416375, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION THAT THE PATIENT HAD A REVISION PERFORMED ON (B)(6) 2015 WHERE THEIR ENTIRE INS SYSTEM EXPLANTED AND A NEW INS AND LEADS IMPLANTED. THE PATIENT WAS SEEN ON A POST-OP VISIT ON (B)(6) 2015 WHERE IT WAS NOTED THAT THEY HAD A SMALL AMOUNT OF INCISIONAL PAIN BUT THEY UNDERSTOOD THAT THIS WAS NORMAL. SOME MINOR REPROGRAMMING WAS PERFORMED TO IMPROVE THE PATIENT'S COVERAGE. THE PATIENT WAS REPORTED AS RECEIVING EFFECTIVE COVERAGE AT THE TIME OF REPORT BUT MAY NEED A LITTLE "TWEEKING" TO GET OPTIMAL THERAPY. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PLAN WAS TO REVISE OR REPLACE THE PATIENT'S ENTIRE SYSTEM. SINCE THE AUTOMOBILE ACCIDENT, SHE WAS NOT GETTING EFFECTIVE THERAPY. THE PATIENT TRIED IT EVERY NOW AND THEN, BUT IT WAS NOT WORKING. THERE WAS NO DATE SCHEDULED FOR THE PROCEDURE AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL EXPERIENCING ISSUES SINCE THEIR MOTOR VEHICLE ACCIDENT. AN MRI HAD BEEN SCHEDULED AND THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 WITH THEIR HEALTHCARE PROFESSIONAL TO REVIEW THE MRI AND DETERMINE THE NEXT STEPS FOR TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR A FULL SYSTEM REPLACEMENT ON (B)(6) 2015 DUE TO A PREVIOUSLY REPORTED CAR ACCIDENT. THE ACCIDENT CAUSED THE WIRES TO "COME LOOSE" AND THE IMPLANTABLE NEUROSTIMULATOR (INS) TO "COME LOOSE" FROM THE POCKET AND IT WAS "JUST HANGING IN THEIR BACK". THEY ALSO NOTED THAT THE DEVICE "SHOCKS" THEM INTERNALLY AND THEIR HIP POPS OUT OF PLACE. THEY STILL WANTED TO CHARGE AND KEEP THE STIMULATION ON BECAUSE IF THEY DON'T HAVE IT ON THEIR FOOT TURNS BLACK AND THEIR TOES CURL WHICH IS CAUSED BY THEIR RSD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SURGING SENSATION AND STIMULATION IN THE WRONG LOCATION. THE PATIENT HAD NO SIGNIFICANT DIFFICULTY RECHARGING BEFORE THE ACCIDENT AND SHE RECHARGED EVERY 18 DAYS, BUT SINCE THE ACCIDENT, IT HAD BEEN MUCH MORE FREQUENT CHARGING. THERE HAD BEEN AN INCREASE IN THE PARAMETERS SINCE THE ACCIDENT. THE MANUFACTURING REPRESENTATIVE HAD NOT VERIFIED THIS WITH THE RECHARGER OR THE CLINICIAN PROGRAMMER. THE MANUFACTURING REPRESENTATIVE TRIED REPROGRAMMING MULTIPLE TIMES, BUT SINCE THE ACCIDENT, THEY HAD NOT BEEN ABLE TO RECREATE PARESTHESIA IN THE LEFT FOOT. THE PATIENT RECEIVED SURGES OF STIMULATION THAT OCCURRED SOMETIMES OR RANDOMLY AND WERE NOT PARTICULAR TO A POSITION. IT "TOOK HER KNEES OUT FROM UNDERNEATH HER." THE DEVICE WAS ORIENTATED IN THE PROPER DIRECTION IN REGARDS TO ADAPTIVE STIMULATION. THE IMPEDANCES WERE CHECKED AT 1.5V AND THE MANUFACTURING REPRESENTATIVE WENT THROUGH ALL 16 REFERENCE ELECTRODES. THEY ALL SHOWED 400-1000 OHMS. IMAGING WAS PERFORMED AND THERE WAS NOT A SIGNIFICANT SHIFT OF THE LEAD. PRIOR TO THE ACCIDENT, THE PATIENT ONLY HAD PARESTHESIA FROM THE KNEE TO THE FOOT. AT THE TIME OF THE REPORT, ANY PROGRAMMING ON THE LEAD ON THE LEFT SIDE GAVE THE PATIENT FEELING MORE IN HER HIP ACROSS THE ABDOMEN AND DOWN TO THE KNEES. THIS WAS CONSIDERED BILATERAL. THE PATIENT CHARGED TO 100% ON EVENING AND THEN WOKE UP AND HER DEVICE WAS AT 25%. THIS OCCURRED RECENTLY AFTER THE ACCIDENT. THE PLAN AT THE TIME OF THE REPORT WAS TO REPLACE THE ENTIRE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REPROGRAMMING WAS BEING DONE THE DAY OF THIS REPORT DUE TO THE PATIENT BEING IN A CAR ACCIDENT A COUPLE WEEKS PRIOR TO THIS REPORT AND HAVING NEW NEEDS FOR STIMULATION. A SURGING SENSATION WAS NOTED. THE SURGING WAS STATED TO HAVE STARTED FOLLOWING BEING REAR-ENDED IN HER CAR. THE SURGES WOULD START IN HER BACK AND THEN COME AROUND TO HER FRONT AND IN HER GROIN AREA. THEY ALSO WERE FELT IN BOTH OF HER LEGS. THE SURGING WAS NOTED TO BE RANDOM AND NOT RELATED TO MOVEMENT OR POSITION. THIS WOULD OCCUR WHILE BOTH SITTING AND WALKING. IT WAS OCCURRING SPORADICALLY BUT BECOMING MORE FREQUENT. ON SOME OCCASION, THE INTENSITY HAD FORCED THE PATIENT TO HER KNEES. FLUOROSCOPY INDICATED NO MOVEMENT OF THE LEADS AND THE PATIENT WAS STILL GETTING STIMULATION COVERAGE IN THE MID-THIGH TO FOOT TARGET WHERE SHE WAS RECEIVING STIMULATION BEFORE THE ACCIDENT. THE PATIENT NEEDED STIMULATION FOR COMPLEX REGIONAL PAIN SYNDROME IN HER LEFT FOOT. BLADDER INCONTINENCE ALSO OCCURRED SINCE THE ACCIDENT AND WAS GETTING WORSE WITH TIME. IT WAS MORE DIFFICULT TO GET COUPLING BARS WHEN CHARGING SINCE THE ACCIDENT. PRIOR TO THE ACCIDENT, 8 BARS WAS EASY TO GET BUT ON THE DAY OF THIS REPORT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD TO BE PUSHED HARD TO GET 6-8 BARS. IT WAS THOUGHT THAT THE INS MAY HAVE BECOME TILTED BUT IT WAS UNSURE IF IT WAS FROM THE ACCIDENT OR IF IT HAD ALWAYS BEEN THAT WAY. NO COUPLING ISSUES HAD OCCURRED PRIOR TO THE ACCIDENT. THE PATIENT HAD BEEN USING THE ADAPTIVE STIMULATION FEATURE BUT RECEIVED A MANUAL MODE PROGRAM AFTER THE ACCIDENT. THE SAME SYMPTOMS STILL OCCURRED. WITH STIMULATION OFF, THE PATIENT WAS FEELING PARESTHESIA. IT WAS UNKNOWN IF THE PATIENT SYNCED UP DURING SURGING AND IF THE VOLTAGE APPEARED APPROPRIATE. IT WAS THOUGHT THAT IT WAS THE LEADS IN THE LOWER THORACIC LEVEL. IT WAS UNKNOWN IF THE LATERAL FLUOROSCOPY VIEWS WERE OF THE LEAD. AN MRI WAS PLANNED TO GET FURTHER DETAILS. FOLLOW-UP WAS CONDUCTED TO DETERMINE WHAT WAS FOUND FROM THE MRI, IF REPROGRAMMING HAD PRODUCED RESULTS, AND IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. A FOLLOW-UP REPORT WILL BE INITIATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601783 RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention