BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2803200 · Received October 24, 2012

    Report

    Report Number
    3007566237-2012-02504
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS DURING IMPLANT SURGERY, WHICH LASTED 7 HOURS. IT WAS UNCLEAR WHAT SPECIFIC COMPLICATIONS OCCURRED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A BLADDER INFECTION AS WELL AS A COLONOSCOPY, BUT IT WAS UNCLEAR IF THIS WAS RELATED TO THE SURGERY. IT WAS NOTED THAT THE PATIENT WAS TRYING TO FIND A NEW DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT IMPLANTED. THIS WAS REITERATED ON (B)(6)-2012. THE PATIENT WAS NEVER IMPLANTED BY THE HEALTH CARE PROVIDER (HCP) ORIGINALLY MENTIONED. IT WAS UNCLEAR IF THE PATIENT WAS EVER SEEN BY THE ORIGINAL HCP PROVIDED AND THERE MAY HAVE BEEN 'A MIX UP.' ON (B)(6)-2012 IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH A DIFFERENT HCP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention