BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLTERA

    MDR report key: 1062929 · Received June 19, 2008

    Report

    Report Number
    2182207-2008-03357
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION FOLLOWING REPLACEMENT OF HIS RIGHT NEUROSTIMULATOR. NO SYMPTOMS WERE REPORTED. THE PT'S NEUROSTIMULATOR WAS REMOVED. AFTER THE INFECTION WAS RESOLVED, THE PT WAS REIMPLANTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLTERA MHY MEDTRONIC NEUROMODULATION 7462 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL LEADMVD LOT# UNK| IMPLANTED