BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3973803 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13852
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 10, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37092, LOT# 273040001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO GET COMFORTABLE STIMULATION WITH THE RIGHT LEAD. IT WAS NOTED THAT IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. IT WAS FURTHER NOTED THAT HIGH IMPEDANCES WERE MEASURED ON ELECTRODES ONE AND FOUR. THE REPORTER STATED THEY WERE ABLE TO PROGRAM AROUND THE ELECTRODES TO RECAPTURING THE PATIENT¿S LEFT BACK COVERAGE. THE REPORTER FURTHER STATED THEY WERE ABLE TO REPROGRAM AROUND ELECTRODES ON THE LEFT CHANNEL ELECTRODES 0-7. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WAS UNABLE TO GET GOOD STIMULATION COVERAGE ON THE PATIENT¿S RIGHT CHANNEL ELECTRODES 8-15 AS IT PRODUCED MUSCLE TIGHTENING. IT WAS FURTHER NOTED THAT THERE WAS LEAD MIGRATION. THE REPORTER STATED THE PATIENT WAS GOING TO TRY STIMULATION ON THE LEFT SIDE AND DETERMINE IF THE PAIN RELIEF WAS ACCEPTABLE. THE REPORTER FURTHER STATED THE PATIENT DID NOT WANT TO REVISE THE LEAD AT THIS TIME. IT WAS NOTED THE PATIENT WAS TO CONTACT THEIR HEALTHCARE PROFESSIONAL IF THEY CHANGED THEIR MIND AFTER USING THE NEW SETTINGS. IT WAS NOTED THE PATIENT HAD A LOSS OF GOOD STIMULATION ON THEIR RIGHT BACK. IT WAS FURTHER NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. 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
    451348 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR