BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1997358 · Received February 15, 2011

    Report

    Report Number
    3007566237-2011-01141
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INTRA-OPERATIVELY, IMPEDANCES WERE IN 800-900 OHM RANGE. WHEN THE PT WAS PLACED SUPINE ALL IMPEDANCES WERE GREATER THAN 40,000 OHMS WHEN TESTED AT 3.0V. THE OUTCOME IS UNK. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1