BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4950389 · Received July 29, 2015

    Report

    Report Number
    3004209178-2015-14290
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 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 Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID:37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V952317, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V911920, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HEADACHE DUE TO FALLING OUT OF THE BED ON THE MORNING OF (B)(6) 2015. THE PATIENT INDICATED HE HAD HIT ONE OF THE PROBES WHEN HE FELL. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS GOING TO BE DONE DUE TO THE HEADACHES. THERE WAS SUSPECTED A DEVICE OR THERAPY PROBLEM. STEPS TAKEN TO RESOLVE THE HEADACHE OR OTHER ISSUE RELATED TO THE FALL INCLUDED TAKING EXTRA STRENGTH TYLENOL FOR EIGHT HOURS. THE HEADACHE OR ISSUE RELATED TO THE FALL WAS RESOLVED. POOR BALANCE HAD LED TO THE FALL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD BEEN IN FOR OBSERVATION FOR A FEW DAYS, (B)(6) 2015. NO COMPUTERIZED TOMOGRAPHY (CT) WAS DONE AND HEADACHES LASTED FOR A FEW DAYS AND HAD RESOLVED BY THE TIME HE HAD BEEN ADMITTED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494941 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization