BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3120859 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07941
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 1, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION FOLLOWING IMPLANT ONE WEEK PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT WAS IN THE CLINIC FOR A FOLLOW-UP APPOINTMENT AND FIRST PROGRAMMING OF HER SYSTEM ON THE DAY OF THE REPORT. STIMULATION WASN¿T TURNED ON UNTIL THE DAY OF THE REPORT AND ALL IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS NOTED STIMULATION WAS ¿TURNED UP TO 10 VOLTS¿ AND THE PATIENT FELT NO STIMULATION. IT WAS NOTED THE PATIENT WAS REPROGRAMMED TO A ¿SIMPLE BIPOLE PAIR WITH IMPEDANCE AT 567 OHMS" AND STIMULATION WAS RUN UP TO 9.0 VOLTS AND THE PATIENT ¿COULD BARELY FEEL A SMALL TINGLING FEELING.¿ IT WAS FURTHER NOTED THE PATIENT WAS REPROGRAMMED ¿USING 4+ ELECTRODES AT TOP OF LEAD AND 4- ELECTRODES AT BOTTOM OF THE LEAD AND RAN IT AT 6.0 VOLTS¿ AND THE PATIENT COULD FEEL STIMULATION AT A LOCATION ¿HIGHER THAN THE SHOULDER BLADES¿ THAT RELIEVED THE PATIENT'S INCISION PAIN. IT WAS NOTED ADDITIONAL PROGRAMMING WOULD BE DONE TO SEE IF STIMULATION WOULD IMPROVE OVER THE NEXT FEW WEEKS. IT WAS NOTED IMPEDANCES WERE ¿NORMAL¿ AT IMPLANT AND STIMULATION WAS NOT PREVIOUSLY TURNED ON. ADDITIONAL INFORMATION REPORTED THE PATIENT¿S STIMULATION WAS TURNED OFF. THE REPORTER STATED THAT THE PATIENT WAS SENT HOME THE PREVIOUS DAY WITH ¿ALL ELECTRODES LIT UP.¿ IT WAS NOTED THE PATIENT WAS ONLY FEELING STIMULATION AT THE SITE OF THE LEAD INSERTION. THE REPORTER STATED ¿NO MATTER WHERE THEY PROGRAMMED THE PATIENT, SHE ONLY FELT IT AT THE LEAD SITE.¿ THE REPORTER FURTHER STATED ¿THIS WAS ACCEPTABLE TO THE PATIENT BECAUSE SHE HAD BEEN COMPLAINING MORE OF INCISION PAIN AT THE LEAD SITE.¿ IT WAS NOTED THE PATIENT STATED ¿STIMULATION WAS CONTROLLING HER SITE PAIN.¿ IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS FULL THE PREVIOUS DAY, BUT THE PATIENT REPORTED THE ¿BATTERY WAS EMPTY PER PATIENT PROGRAMMER.¿ IT WAS FURTHER NOTED THE PATIENT RAN ¿GROUP IMPEDANCE YESTERDAY AND NOTED THAT IT WAS SHOWING LESS THAN 150 OHMS WITH STIMULATION AT 6 TO 6.5 VOLTS.¿ ADDITIONAL INFORMATION REPORTED AN X-RAY SHOWED THE LEAD WAS OUT OF THE EPIDURAL SPACE AND A REVISION WAS PLANNED. ADDITIONAL INFORMATION REPORTED THE LEAD WAS PLACED ¿BACK INTO PROPER EPIDURAL POSITION AND ANCHORED TO THE LAMINA.¿ IT WAS NOTED THE PATIENT WAS GETTING ¿PERFECT COVERAGE AND IMPEDANCE.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANT WAS NOT RIGHT THE FIRST TIME AND COST TWO SURGERIES AND TWO OPERATIONS TO FIX IT. IT WAS NOTED THAT THE PATIENT WAS REALLY EXASPERATED. IT WAS NOTED THAT THE PATIENT WAS SEEING A SURGEON NEXT WEEK AND WOULD DISCUSS WITH THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222074 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 Required Intervention