BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 6112556 · Received November 18, 2016

    Report

    Report Number
    3004209178-2016-24322
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 21, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# V042627, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THERE WAS AN IMPEDANCE CHECK PRE-OPERATIVELY AND THAT ELECTRODE 0 SHOWED GREATER THAN 10,000 OHMS. THE PATIENT WAS NOT USING THIS ELECTRODE WITH PROGRAMMING. THE PATIENT HAD BEEN SEEN PRE-OPERATIVELY FOR BATTERY REPLACEMENT FOR A TYPICAL END OF LIFE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. A SURGICAL INTERVENTION OCCURRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO SYMPTOMS RELATED TO THE HIGH IMPEDANCE ISSUE. THE BATTERY WAS REPLACED. THE LEAD WAS NOT REPLACED DUE TO GOOD COVERAGE. THE PATIENT WAS GOING TO CONTINUE TO USE THE LEAD WITH PROGRAMMING AROUND ELECTRODE 0 AND THEY WERE RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763119 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR