BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4121543 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17792
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 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 PRODUCTS: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N236885, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-29, LOT# N227641, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601605 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 Required Intervention