BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3934235 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13008
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA0APC0, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# VA0A2FN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4). THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS DEPRESSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT AND NEEDED DIAGNOSTIC TESTING. THE TESTING WAS A PRECAUTIONARY MEASURE DUE TO THE ACCIDENT, EVEN THOUGH THE PATIENT DID NOT APPEAR TO BE VERY INJURED. THE REPORTER NOTED THAT THE PATIENT WAS UNABLE TO TOLERATE BEING TURNED OFF. THE REPORTER WAS UNSURE IF THE DEVICE WAS FUNCTIONING. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3007566237-2014-01866.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. ON (B)(6) 2014, THE PATIENT LOST CONTROL OF HER CAR AND STRUCK A GUARD RAIL. THE PATIENT SUSTAINED SOME BRUISING, BUT WALKED AWAY OTHERWISE UNINJURED. AN ELECTROCARDIOGRAM (EKG) REVEALED NO CLINICALLY SIGNIFICANT FINDINGS OTHER THAN PREVIOUSLY DOCUMENTED ISSUES. A NEW CT REVEALED NO ACUTE PATHOLOGY. AS A PRECAUTIONARY MEASURE, THE PATIENT¿S STIMULATION WAS REDUCED FROM 9.0 TO 7.5 VOLTS, AS WELL AS HER MEDICATION DOSAGE. THE CAUSE OF THE ISSUE REMAINED UNKNOWN AND WAS NOT DETERMINED TO BE A DEVICE EFFECT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413431 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR