BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4171034 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02977
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE DEVICE POCKET. IT WAS UNKNOWN WHAT THE INFECTION TYPE WAS OR IF A CULTURE HAD BEEN TAKEN. THE EVENT WAS RESOLVED BY EXPLANT AND ANTIBIOSIS. ANTIBIOTICS WERE NECESSARY FOR TREATMENT. IT WAS NOTED THEY INTENDED TO RE-IMPLANT THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REIMPLANTED ON (B)(6) 2015, AND THE PATIENT RESOLVED. FOLLOW UP IS BEING CONDUCTED TO CLARIFY IF THEY MEANT THE PATIENT WAS REIMPLANTED AND RESOLVED ON (B)(6) 2014, INSTEAD OF (B)(6) 2015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED AFTER EXPLANT ORAL ANTIBIOSIS BLOOD MARKERS WERE CHECK BY A GENERAL PRACTITIONER REGULARLY BEFORE RE-IMPLANTATION. NO SPECIAL DIAGNOSTICS WERE PERFORMED TO ASSESS THE TYPE OF INFECTION. CLARIFICATION WAS ALSO RECEIVED CONFIRMING RE-IMPLANT OCCURRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651918 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention