BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3830873 · Received May 23, 2014

    Report

    Report Number
    6000153-2014-00105
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNRESPONSIVE POST-OPERATIVELY FROM STAGE 1 LEAD PLACEMENT. BOTH LEADS WERE IMPLANTED WITH NORMAL PROCEDURES, BUT THE PATIENT WAS GRADUALLY LETHARGIC AND BECAME UNRESPONSIVE. THE DOCTOR ORDERED A CT SCAN AND DISCOVERED A SMALL BLEED IN THE THALAMUS AND SUBTHALAMIC AREA ON THE LEFT. THE PATIENT WAS HOSPITALIZED AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND SLOWLY RECOVERING FROM WHAT SOUNDED LIKE MILD RIGHT HEMIPARESIS. THE PATIENT WAS TENTATIVELY SCHEDULED FOR THE SECOND PART OF THE PROCEDURE ON (B)(6) 2014. THE LAST REPORT STATED THAT THE SYMPTOMS WERE RESOLVING AND THE PATIENT WAS RECOVERING WELL. THE PATIENT HAD GRADUALLY IMPROVED IN ALERTNESS AND HAD FUNCTION OF HER RIGHT EXTREMITIES, BUT THEY WERE A LITTLE CLUMSY RELATIVE TO THE LEFT. THE NEUROLOGIST AND NEUROSURGEON EXPECTED A FULL RECOVERY FROM THE INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SLOWLY RECOVERING AND WAS UNDERGOING REHAB. THE PATIENT¿S MOBILITY AND UPPER EXTREMITY USE WAS PRETTY MUCH RESTORED CLOSE TO BASELINE PER THE NEUROLOGIST. THE PATIENT¿S SPEECH WAS STILL SOFT AND IMPAIRED, BUT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307924 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA0H1RY

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization