BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1910623 · Received November 19, 2010

    Report

    Report Number
    9614453-2010-09808
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    THE DEEP BRAIN STIMULATOR REACHED END OF SERVICE. THE HCP THOUGHT THE DEVICE REACHED END OF SERVICE SOONER THAN EXPECTED. THE DEVICE WAS REPLACED. THERE WAS NO PT INJURY ASSOCIATED WITH THE EVENT. THE PT RECOVERED WITHOUT SEQUELA AFTER REPLACEMENT. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED 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