BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 4976986 · Received August 6, 2015

    Report

    Report Number
    3004209178-2015-15554
    Event Type
    Death
    Date Received
    August 6, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED VIA THE MANUFACTURER REPRESENTATIVE (REP) THAT BEFORE REPLACEMENT THE PATIENT WAS ¿BUMPED OUT LATER THAN EXPECTED,¿ WHICH CAUSED HIM TO MISS HIS USUAL DOSE OF MEDICATION. HE WAS GIVEN SINEMET AND IT WAS USUALLY CRUSHED BECAUSE HE HAD TROUBLE SWALLOWING. HIS INDICATIONS FOR USE WERE PARKINSON¿S DUAL AND MOVEMENT DISORDERS. SINCE THE PATIENT¿S BILATERAL IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT HIS HEALTH HAD TAKEN A ¿TURN FOR THE WORSE¿ AND HE WAS TERMINAL. HIS STIMULATION SETTINGS HAD BEEN DROPPED BY 25% DUE TO THE CHANGE IN PRODUCT. THE REP TRIED TO SCHEDULE A TIME TO CHECK THE INSS, BUT THEN THE PATIENT DIED. THE PATIENT¿S DAUGHTER STATED HE WAS NON-RESPONSIVE PRIOR TO HIS DEATH. THE CAUSE OF DEATH WAS UNKNOWN, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #(B)(4) AS THE PATIENT HAD TWO INSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519452 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death