BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1082491 · Received July 25, 2008

    Report

    Report Number
    3004209178-2008-04375
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    January 1, 2003
    Report Date
    June 26, 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
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTED INVOLVES RIGHT LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING A BURNING SENSATION ON THE RIGHT SIDE OF THE HEAD WHERE THE DBS LEAD IS. THERE WAS NO KNOWN INCIDENT RELATED TO THE SYMPTOMS WHICH REPORTEDLY STARTED 5 YEARS AGO. IT WAS ALSO REPORTED THE PATIENT HAS EXPERIENCED JOLTING WHICH STARTED ABOUT 2 YEARS AGO.

    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 Required Intervention IMPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NGK019466N| EXPLANTED:| PROGRAMMER MODEL 7438 LOT# NHL006171P| LEAD MODEL 3389 LOT# J0237043V| EXPLANTED: