BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4996305 · Received August 12, 2015

    Report

    Report Number
    3004209178-2015-15871
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    January 1, 2013
    Report Date
    July 20, 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
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 387S-40, LOT# V053450, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V055601, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD, PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE PATIENT HAD PROBLEMS THINKING AND A FALL WITH A HEAD INJURY A COUPLE YEARS AGO. THE PATIENT HAD BEEN HAVING PROBLEMS THINKING AND PASSING OUT THAT STARTED A COUPLE YEARS AGO. THIS WAS BETTER FOR A WHILE, BUT IT HAD STARTED AGAIN. THREE WEEKS AGO, THE PATIENT BLACKED OUT, FELL, AND HIT THEIR HEAD. THE PATIENT STATED IT HURT UNDERNEATH THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT THEY HAD NOT COMPLAINED UNTIL A FEW WEEKS AFTER THE FALL. THE REPORTER DID NOT THINK THE INS WAS AFFECTED BECAUSE THEY WOULD KNOW IF IT WAS NOT WORKING. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527932 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other