BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1919934 · Received November 30, 2010

    Report

    Report Number
    9614453-2010-10012
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE IMPLANTABLE NEUROSTIMULATOR HAS BEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE STIMULATION STOPPED SUDDENLY. IT WAS IMPOSSIBLE TO INTERROGATE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS THOUGHT THAT THE EVENT MAY BE RELATED TO NORMAL BATTERY DEPLETION; HOWEVER, IT WAS ALSO THOUGHT THAT IT MAY BE A DEVICE DYSFUNCTION BECAUSE OF THE ABRUPT TOTAL DEPLETION. THE INS PARAMETERS WERE (UNIPOLAR: ELECTRODES 2 AND 3 NEGATIVE; AMPLITUDE: 2, 1 V; PULSE WIDTH: 30 MICRO S; AND FREQUENCY : 130 HTZ). THE INS WAS REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention