BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1800025 · Received August 12, 2010

    Report

    Report Number
    3007566237-2010-06084
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 14, 2010
    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

    AN IMPEDANCE READING GREATER THAN 10000 OHMS WAS REPORTED. IT WAS NOTED THAT THE PT'S THERAPY LEVEL WAS LOW, AND IT WAS QUESTIONABLE IF THE PT COULD TOLERATE MOVING UP TO A HIGHER IMPEDANCE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1