BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4693815 · Received April 15, 2015

    Report

    Report Number
    3004209178-2015-07264
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 64002, LOT # N248030, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V050963, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V050963, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S NEUROLOGIST CALLED THE MANUFACTURER REPRESENTATIVE (REP) AND ASKED WHICH X-RAYS WOULD PROVIDE THE BEST IMAGE OF THE IMPLANTABLE NEUROSTIMULATOR (INS), EXTENSIONS, AND LEADS. THE PATIENT SELF-ADMITTED TO THE EMERGENCY ROOM (ER) THE MORNING OF THE REPORT; HE HAD PAIN ON THE RIGHT SIDE OF THE NECK AND A RETURN OF SYMPTOMS, INCLUDING SPEECH DEGRADATION AND A CHANGE IN GAIT. IT WAS CONSIDERED A SUDDEN LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE INS WAS CHECKED BY THE NEUROLOGIST USING A CLINICIAN PROGRAMMER AND IT APPEARED TO BE ON WITHOUT ANY PROBLEMS. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT AND WAS REFERRED BACK TO THE ORIGINAL IMPLANTING PHYSICIAN FOR EVALUATION. NO SURGICAL INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250829 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization