BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1831838 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06879
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PATIENT HAD HER CARDIAC DEVICE INTERROGATED, THE DEEP BRAIN STIMULATION SOLETRAS WERE GOING BACK TO FACTORY SETTINGS. PATIENT'S CARETAKER STATED, DEVICES WERE ONLY 1-2 INCHES APART. PATIENT'S CARETAKER WAS REDIRECTED TO HCP. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE. FOR PREVIOUSLY REPORTED LEAD REVISION REFER TO MFR # 3004209178-2010-06878.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 7482, LOT# NHU026159V| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL008176P| EXPLANTED:| LEAD: MODEL 3389, LOT# J0340323V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# J0340570V| EXPLANTED:| IMPLANTED:| LOT# NFW152099H| EXTENSION: MODEL 7482, LOT# NHU019825V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426