BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4977096 · Received August 6, 2015

    Report

    Report Number
    3004209178-2015-15570
    Event Type
    Injury
    Date Received
    August 6, 2015
    Report Date
    July 17, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    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) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389-40, LOT# L84348, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389-40, LOT# L84348, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389-40, LOT# L84348, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389-40, LOT# L84348, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT¿S SYMPTOMS HAD RETURNED AND THEY COULD NOT ¿STAND SIT DOWN OR EAT AND SLEEP¿ BEGINNING IN (B)(6) 2015. A LOSS OF STIMULATION AND THERAPY WAS REPORTED. THE PATIENT WAS ON MEDICATION, BUT THIS WAS NOT HELPING. THE PATIENT WAS ALSO DROWSY AND WAS SAID TO HAVE HALLUCINATIONS AT NIGHT. THE CONSUMER WANTED TO HAVE THE DEVICE CHECKED BECAUSE THEY THOUGHT THE BATTERY WAS LOW OR DEPLETED, HOWEVER THE PATIENT PROGRAMMER HAD NOT BEEN USED TO CHECK THE DEVICE BECAUSE THEY WERE AFRAID TO USE IT. NO DIAGNOSTICS/TROUBLESHOOTING, ACTIONS/INTERVENTIONS, OR PATIENT OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. INDICATION FOR USE: MOVEMENT DISORDERS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT MET WITH THEIR HEALTHCARE PROFESSIONAL AND THE VOLTAGE WAS CHECKED AND WAS FINE. THE DEVICE WAS WORKING AS INTENDED. THE HEALTHCARE PROFESSIONAL DECIDED IT WAS A MEDICATION ISSUE AND MEDICATIONS WERE ADJUSTED. THE PATIENT WAS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519701 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other