BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3960762 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13574
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 9, 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 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR OFF FOR A COUPLE OF MONTHS DUE TO LACK OF STIMULATION. IT WAS STATED THAT THERAPY WASN¿T WORKING PROPERLY, SO THE PATIENT GOT FRUSTRATED AND TURNED IT OFF. IT WAS CLARIFIED THAT THERAPY WASN¿T DELIVERING STIMULATION TO THE CORRECT AREA. THE PATIENT WOULD GET STIMULATION BUT INTENSITY WAS DULL. WHEN THE PATIENT MOVED STIMULATION WOULD COME BACK. ADAPTIVESTIM WAS REPORTED TO NOT SEEM TO BE WORKING CORRECTLY, FOR EXAMPLE IT WAS TOO STRONG WHEN LYING BACK. IT WAS SUSPECTED IT MAY NEED TO BE REORIENTED. ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCES WERE REPORTEDLY CHECKED. IT WAS NOTED IMPEDANCES HAD BEEN HIGH ON CONTACTS 8-15. IT WAS NOTED THIS LIMITED THE THERAPY ON THE LEFT LEG THAT WAS GETTING STIMULATION, BUT NOT OPTIMUM. THE PATIENT WAS REPROGRAMMED TO OBTAIN MAXIMUM THERAPEUTIC COVERAGE GIVEN THE LIMITATIONS. THE PHYSICIAN WAS NOTIFIED AND WOULD CONSIDER A REVISION. THE PHYSICIAN HAD NOT GIVEN THE MANUFACTURER REPRESENTATIVE (REP) A DECISION ON WHAT HE PLANNED ON DOING. THE PATIENT WAS RECEIVING THERAPY, BUT IT WAS NOT OPTIMUM GIVEN THE ¿LIMITATIONS MENTIONED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437701 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 00051 YR