BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5994719 · Received October 3, 2016

    Report

    Report Number
    3004209178-2016-20270
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 12, 2016
    Report Date
    October 3, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# VA0H2ZN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA0H1PY, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT A LEAD REVISION SURGERY WAS PERFORMED AS THE LEAD WAS PLACED IN THE GPE RATHER THAN THE GPI. IT IS UNKNOWN IF THE LEAD MIGRATED OR WAS PLACED IN THE INCORRECT LOCATION. DURING THE MICROELECTRODE RECORDING, THE PATIENT BECAME UNRESPONSIVE SO THE RECORDING WAS STOPPED AND A CT SCAN WAS PERFORMED. THE CT SCAN RESULTED IN THE IDENTIFICATION OF A HEMATOMA THAT WAS RELATED TO THE UNRESPONSIVENESS. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM THE SAME EVENING AND THE CLOT WAS REMOVED. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT FOR RECOVERY AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SCHEDULED FOR A LATER DATE. PLEASE SEE REPORT NUMBER 3004209178-2016-20269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645679 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R