BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1961586 · Received December 27, 2010

    Report

    Report Number
    3007566237-2010-10762
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFO REC'D FROM A PHYSICIAN STATES IMPEDANCES >2000 OHMS ON ALL OF THE UNIPOLAR PAIRS. HCP DID THRESHOLD TESTING AND DID NOT ELICIT ANY SIDE EFFECTS. A READING OF >12 MICROAMPS EQUATES TO AN OPEN CIRCUIT AND HCP WAS GETTING 11UA. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1