BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1061820 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03228
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION TURNS ON AND/OR OFF. THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PT WAS AT HOME AT THE TIME OF THE REPORT. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL 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 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR EXTENSION MODEL 7482| EXPLANTED:| LEAD MODEL 3387| EXPLANTED: