BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1181216 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06234
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 31, 2007
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE EXTENSION WAS FRACTURED. THE EXTENSION WAS REPLACED. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention PROGRAMMER MODEL 7438 LOT #NHL019090P| EXPLANTED| EXTENSION MODEL 7482 LOT #NHU145079V IMPLANTED| LEAD MODEL 3387 LOT #V004552 IMPLANTED| EXPLANTED