BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5721983 · Received June 13, 2016

    Report

    Report Number
    3004209178-2016-12069
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    February 1, 2016
    Report Date
    July 25, 2016
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) HAD NOT HAD A FOLLOW UP VISIT WITH THE PHYSICIAN. THE REO HAD NOT BEEN INFORMED OF ANY OTHER INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT HAD A LACK OF COVERAGE. THE PATIENT HAD A FALL APPROXIMATELY3 MONTHS PRIOR TO THE REPORT ((B)(6) 2016). AN IMPEDANCE CHECK WAS RUN AND ALL IMPEDANCES WERE ABOVE 10,000 OHMS. THE MANUFACTURER REPRESENTATIVE REPROGRAMMED THE ELECTRODES AND SUCCESSFULLY ACHIEVED APPROPRIATE COVERAGE. THE HEALTH CARE PROVIDER IS FINE LEAVING THE SYSTEM AS IT IS AS LONG AS THE PATIENT IS RECEIVING COVERAGE. THE PATIENT CONFIRMED THE COVERAGE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375375 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 50 YR