BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5566788 · Received April 11, 2016

    Report

    Report Number
    3004209178-2016-07149
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 1, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 399930, LOT# V182611, IMPLANTED: (B)(6) 2009, 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 HEALTHCARE PROVIDER (HCP) REPORTED THE PHYSICIAN JUST CHECKED THE CONSUMER'S DEVICE AND IMPEDANCE TESTING SHOWED CONTACT EIGHT WAS GREATER THAN 10,000 OHMS. IT WAS UNKNOWN IF THE CONSUMER HAD A FALL. RELEVANT MEDICAL HISTORY INCLUDES CHRONIC LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222784 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 75 YR