BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5152903 · Received October 15, 2015

    Report

    Report Number
    3004209178-2015-20721
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 22, 2015
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37083-20, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT # N198811, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3986A, LOT # N202582, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708320, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748966, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7425, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3587A, LOT # N087251, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE POWER ON RESET (POR) INCLUDED THE PATIENT BEGAN TO RECEIVE ELECTRICAL STIMULATION TO HEALTH NERVES, AND WHEN THE PATIENT WOULD TURN OFF THE UNIT IT WOULD AT TIMES REMAIN ON. THE PATIENT COULD NOT USE IT DURING MUSCLE SPASMS AS THE UNIT WOULD OFTEN THROW ELECTRICAL STIMULATION DOWN THE BACK AND LEGS. THERE HAD BEEN NO SIGNIFICANT CHANGE IN ACTIVITY LEVEL. THE PATIENT HAD COMPLETE CONTROL OF PROGRAMMING THE DEVICE AND TRIED VARIOUS COMBINATIONS. IT CAME TO A POINT WHERE IN ORDER TO GET ANY RELIEF FROM THE STIMULATOR SHE HAD TO REMAIN IN A SINGLE POSITION. DURING THIS TIME THE PATIENT BEGAN TO HAVE MOTOR MUSCLE SPASMS THAN HAD CURRENTLY EXPERIENCED. THE INCREASE IN SPASMS BECAME MORE SEVERE DRAWING ALL THE WAY AROUND THE RIGHT SHOULDER AND TORSO. THE PATIENT DEVELOPED TENDONITIS IN THE RIGHT SHOULDER. IT WAS NOTED THE LEFT SHOULDER HAD THE STIMULATION IMPLANT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN¿T RELIEVE THEIR PAIN AND ONLY HELPED 25%. RELEVANT MEDICAL HISTORY INCLUDES MULTIPLE BACK OPERATIONS. THE PATIENT WAS ALSO UNABLE TO TOLERATE POSITIONAL CHANGES. THE BATTERY HAD BEEN DEAD FOR ONE YEAR, AND WHEN THE REP. ATTEMPTED TO INTERROGATE THE BATTERY THEY WERE UNSUCCESSFUL, AND A POWER ON RESET (POR) WAS SEEN. AS A RESULT IT WAS PLANNED FOR THE SYSTEM TO BE EXPLANTED BUT WASN¿T SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685022 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention