BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3327404 · Received September 5, 2013

    Report

    Report Number
    3004209178-2013-15707
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Report Date
    August 9, 2013
    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

    PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 387445, LOT# V882549, IMPLANTED: 2012 (B)(6); PRODUCT TYPE SCREENING DEVICE PRODUCT ID 387445, LOT# V752270, IMPLANTED: 2012 (B)(6); PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441830 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR