BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3339468 · Received September 10, 2013

    Report

    Report Number
    3004209178-2013-15968
    Event Type
    Injury
    Date Received
    September 10, 2013
    Report Date
    August 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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 3389S-40, LOT# VA090AQ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SEIZURE AFTER STAGE TWO IMPLANTABLE NEUROSTIMULATOR (INS) SURGERY. ETIOLOGY WAS NOT RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO IMPLANT PROCEDURE. SIGNS AND SYMPTOMS INCLUDED A SEIZURE WHICH LASTED AROUND ONE MINUTE WITH TONIC CLONIC MOVEMENT AND RESPIRATORY DISTRESS. THE HEALTHCARE PROFESSIONAL (HCP) OBSERVED THE PATIENT HAD GENERALIZED TONIC CLONIC (GTC) AND WAS GRAY IN COLOR. THE SEVERITY WAS SEVERE. IT WAS NOTED THAT IT RESULTED IN IN-PATIENT HOSPITALIZATION FOR SEIZURE MANAGEMENT. DIAGNOSTIC METHODS INCLUDED LAB WORK. THE RESULTS WERE: ELEVATED MEAN CORPUSCULAR HEMOGLOBIN (MCH), ¿LYMPRE¿, ¿LYMPAB¿, ¿NRBC¿, AND ¿GLU.¿ THE PATIENT ALSO HAD AN ELECTROENCEPHALOGRAPHY (EEG). THE RESULT WAS AN ABNORMAL EEG BECAUSE OF CONTINUOUS GENERALIZED SLOW ACTIVITY AND SLOW ¿PDR.¿ TWO CT SCANS WERE CONDUCTED WITH THE SAME RESULT: PNEUMOCEPHALUS OVER THE RIGHT CEREBRAL HEMISPHERE. THE NEXT DAY THE LAB RESULTS WERE ELEVATED ¿GLUBED¿, HEMOGLOBIN (HGB), ¿PCV¿, ¿P¿IT-CT¿, RED BLOOD CELLS (RBC), MCH, ¿NTAUTO¿, ¿NEUTRE¿, ¿LYMPRE¿, ¿EOSIRE¿, ¿NEUTAB¿, ¿EOSIAB¿, ¿CL¿, AND ¿GLUC.¿ THE FOLLOWING DAY THE LAB RESULTS WERE ELEVATED HGB, ¿PCV¿,¿ PLT-CT¿, RBC, MCH, ¿NEUTRE¿, ¿ LYMPRE¿, ¿LYMPAB¿, AND ¿GLUC.¿ THE NEXT DAY THE LAB RESULTS WERE ELEVATED HGB, ¿PCV, ¿PLT-CT¿, RBC, MCH, ¿NEUTRE¿, ¿LYMPRE¿, ¿LYMPAD¿, AND ¿GLUC.¿ THE NEXT DAY THE RESULTS WERE ELEVATED HGB, ¿PCV¿, ¿PLT-CT¿, RBC, MCH, ¿LYMPRE¿, ¿MONORE¿, AND ¿LYMPAB.¿ THE FOLLOWING DAY THE RESULTS WERE ELEVATED HGB, ¿PCV¿, RBC, ¿LYMPRE¿, ¿MONORE¿, ¿LYMPAB¿, AND ¿GLUC.¿ THE NEXT DAY THE RESULTS WERE ELEVATED HGB, ¿PCV¿, RBC, ¿LYMPRE¿, ¿MONORE¿, AND ¿LYMPAB.¿ THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454416 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization