BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3935705 · Received July 15, 2014

    Report

    Report Number
    3007566237-2014-01964
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS MIGRATED. IT WAS NOTED THE X-RAYS WERE DONE. IT WAS FURTHER NOTED THAT AN EXTRA SURGERY WAS NEEDED TO PLACE THE ELECTRODES CORRECTLY. THE REPORTER STATED THAT THE USE OF A BAD MEASUREMENT REFERENCE LED TO AN IMPLANTATION OF THE LEADS DEEPER THAN DESIRED. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS FURTHER NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESULT OF THE SURGERIES WAS AN ERROR IN THE LEAD PLACEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE ERROR WAS CAUSED BY HUMAN ERROR DURING THE CALCULATION OF THE IMPLANTATION DEPTH OF THE LEAD. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412327 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3389-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention