BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3170116 · Received June 14, 2013

    Report

    Report Number
    3007566237-2013-01980
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CLARIFIED THE PATIENT WAS UNRESPONSIVE DURING INSERTION OF THE MICROELECTRODE INTO THE THALAMUS, WITH HYPOTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION DURING THE BEGINNING OF THE SURGICAL PROCEDURE. THERE WAS AN ABNORMAL DROP IN HEART RATE AND BLOOD PRESSURE AFTER THE BURR HOLE WAS DRILLED. IT WAS NOTED THAT IT COULD HAVE BEEN CAUSED BY A REACTION TO THALAMIC PENETRATION. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. (B)(6) 2013 - CLINICAL (HCP/SDY/REP): NO NEW INFO. (B)(6) 2013 - CLINICAL (HCP/SDY/REP): CORRECTED 5-24 ENTRY WITH NEW INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT OUTCOME WAS, AS OF (B)(6) 2013, NOTED AS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271023 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization