BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1842131 · Received September 20, 2010

    Report

    Report Number
    3004209178-2010-07115
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS ON ALL MONOPOLAR SETTINGS. THE NEUROSTIMULATOR WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL #7482, LOT #NHU040832V| EXPLANTED:| IMPLANTED:| LEAD: MODEL #3387, LOT #J0405899V