BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4434518 · Received January 20, 2015

    Report

    Report Number
    3004209178-2015-00939
    Event Type
    Injury
    Date Received
    January 20, 2015
    Report Date
    December 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V091844, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V032588, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD PRODUCT ID: 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR FREQUENT FALLS. IT HAD STARTED ON SUNDAY PRIOR TO THE DATE OF THIS REPORT AND THE PATIENT HAD FALLEN THREE TIMES ON THAT DAY. THE PATIENT¿S BEHAVIORS WERE NOT LIKE THEY USED TO BE, THE PATIENT WAS HALLUCINATING, AGITATED AND COMBATIVE. THEY WANTED A MANUFACTURING REPRESENTATIVE TO COME ASSESS THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD PARKINSON¿S DISEASE. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46098 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization