BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4771432 · Received May 14, 2015

    Report

    Report Number
    3004209178-2015-09096
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0Q81G, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA0Q81G, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ACUTE DELIRIUM. SIGNS AND SYMPTOMS INCLUDED VERBAL AGITATION, CONFUSION, ENCEPHALOPATHY AND SLIGHT SEIZURE ACTIVITY. IT WAS NOTED THAT THE SURGERY/ANESTHESIA WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND IT WAS POSSIBLY RELATED TO IMPLANT PROCEDURE. THE EVENT HAD RESULTED IN IN-PATIENT HOSPITALIZATION AND SEIZURE MEDICATION. LAB WORK RESULTS WERE NEGATIVE FOR AN INFECTION. ELECTROENCEPHALOGRAM (EEG) RESULTS INDICATED NO SEIZURE, NO RHYTHMIC OR PERIODIC PATTERNS, INTERMITTENT BURSTS OF GENERALIZED DELTA ACTIVITY WITH SLOW POSTERIOR DOMINANT RHYTHM (PDR). A COMPUTERIZED TOMOGRAPHY (CT) SCAN WITHOUT CONTRAST RESULTS INDICATED EDEMA IN THE SUPERIOR RIGHT FRONTAL LOBE. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315602 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| O "SEE H10...."