BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3821544 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09288
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0CTZW, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA0CS7A, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, LOT# NKN060779V, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, LOT# NKN060775V, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGERY THE PATIENT HAD BEEN IN A STATE OF A COMA. IT WAS NOTED THAT AFTER THE PATIENT REGAINED CONSCIOUSNESS THE ACTIVITIES OF THE RIGHT LOWER LIMB WAS NOT FLEXIBLE. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NO DIAGNOSTICS WERE PERFORMED, NO MALFUNCTIONS WERE SEEN, AND NO INTERVENTIONS WERE TAKEN OR PLANNED. IT WAS NOTED THAT THE PATIENT LIVED IN THE HOSPITAL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299833 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 NKM722076H

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| O