BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3728878 · Received April 7, 2014

    Report

    Report Number
    6000153-2014-00060
    Event Type
    Injury
    Date Received
    April 7, 2014
    Report Date
    March 12, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 34680, LOT # 203314, PRODUCT TYPE ACCESSORY; PRODUCT ID FC1020, LOT # 203725, PRODUCT TYPE ACCESSORY; PRODUCT ID 924256, LOT # 082226713A, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 3389-28, LOT # 0207763086, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3550-05, LOT # 0207756555, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-05, LOT # 0207756556, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389-28, LOT # 0207763086, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS WERE IMPLANTED ¿OK.¿ AFTER TWO DAYS, THE PATIENT EXPERIENCED SUPERFICIAL FRONTAL HEMORRHAGE. THE PATIENT SUBSEQUENTLY UNDERWENT SURGERY. IT WAS STATED THAT THE PATIENT WAS OKAY AT THE TIME OF THE REPORT AND WAS UNDERGOING REHABILITATION. THE LEADS REMAINED IMPLANTED. APPROXIMATELY A WEEK LATER, IT WAS REPORTED THAT THE ROOT CAUSE FOR THE HEMORRHAGE WAS UNKNOWN. THE SURGERY WAS TO ¿REMOVE AND STOP THE HEMORRHAGING.¿ THE PATIENT WAS DOING ¿QUITE WELL¿ WITH REHABILITATION BUT WAS STILL WITHOUT THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSIONS ON (B)(6) 2014 AND WAS DOING WELL. THE FOLLOWING DAY, IT WAS REPORTED THAT THE INS WAS NOT IMPLANTED AT THE TIME OF THE HEMORRHAGING; ONLY THE LEADS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206450 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389-28 0207763085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention