BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3609138 · Received February 5, 2014

    Report

    Report Number
    3004209178-2014-01623
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Report Date
    January 15, 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: 377845, LOT# V012124, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377845, LOT# V012124, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GETTING AN ELECTRICAL SENSATION DOWN HER ARM EVEN THOUGH THE SYSTEM WAS OFF. A MANUFACTURER REPRESENTATIVE CONFIRMED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF AND SHE CHANGED THE AMPLITUDES TO 0 VOLTS AND THE PATIENT STILL HAD THE ELECTRICAL SENSATIONS WHICH WERE ALSO DESCRIBED AS A SHOCKING FEELING. THE PATIENT FELT THE ELECTRICAL SENSATIONS IN THE SAME PLACE SHE WOULD NORMALLY FEEL STIMULATION OF THE STIMULATOR WAS TURNED ONE. IT WAS NOTED THE INS WAS REPLACED LAST YEAR AND AT THAT TIME THE PATIENT WAS GETTING GOOD STIMULATION AND DID NOT HAVE THIS ELECTRICAL SENSATION. WHEN THE CLINICAL PROGRAMMER WAS HOOKED UP THERE WERE HIGH IMPEDANCES NOTED ON ELECTRODES 1-3. BECAUSE THEY WERE ABLE TO REPROGRAM AROUND CONTACTS 1-3 AND GET GOOD STIMULATION THEY DID NOT REPLACE THE LEADS OR EXTENSIONS AT THE TIME. IT WAS NOTED THE PATIENT HAD NOT BEEN EVALUATED BY A HEALTHCARE PROVIDER YET. ADDITIONAL INFORMATION RECEIVED SIX DAYS LATER REPORTED THE PATIENT WAS PURSUING ANSWERS FROM FURTHER TESTING OF HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73722 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 00054 YR