BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2919169 · Received January 16, 2013

    Report

    Report Number
    3004209178-2013-00686
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 24, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V210850, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD REVISION ON (B)(6) 2012 TO REMOVE THE LEAD FROM THE RIGHT SUBTHALAMIC NUCLEUS AND IMPLANT THE RIGHT INTERNAL GLOBUS PALLIDUS. THE EXISTING EXTENSION WAS RECONNECTED. FOUR DAYS LATER, IT WAS REPORTED THAT THE CAUSE OF THE LEAD REVISION WAS UNKNOWN AND THE PATIENT OUTCOME WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24715 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention