BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4507161 · Received February 11, 2015

    Report

    Report Number
    3004209178-2015-02812
    Event Type
    Injury
    Date Received
    February 11, 2015
    Report Date
    January 21, 2015
    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: 3708320, SERIAL# (B)(4), IMPLANTED: 2009-12-16, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708320, SERIAL# (B)(4), IMPLANTED: 2009-12-16, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V258306, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-33, LOT# V182141, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101053 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 Required Intervention