BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3145794 · Received June 4, 2013

    Report

    Report Number
    3004209178-2013-08626
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    May 14, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389S-40, LOT# V012196, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# V185948, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TWO RECENT CARDIOVERSIONS SEVERAL MONTHS APART. DURING THE FIRST CARDIOVERSION THE PATIENT¿S DEEP BRAIN STIMULATION (DBS) SYSTEM WAS TURNED OFF. AT THE PATIENT¿S MOST RECENT CARDIOVERSION HIS PHYSICIAN SUSPECTED THEY DID NOT TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE PHYSICIAN SUSPECTED THE PATIENT HAD A CARDIOVERSION-INDUCED LESION IN THE RIGHT SUB-THALAMIC NUCLEUS (STN). IT WAS NOTED THE PATIENT¿S PHYSICIAN WANTED TO DO AN MRI TO RULE OUT A LESION AND AN MRI WAS SCHEDULED BUT THE PATIENT HAD TO CANCEL. IT WAS NOT KNOWN IF THE PATIENT HAD EXPERIENCED A CHANGE IN THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCES TESTING WAS PERFORMED AND THE PATIENT¿S PHYSICIAN NOTED ¿OPEN CIRCUITS¿ BUT IT WAS UNKNOWN WHICH HEMISPHERE OR ELECTRODE COMBINATIONS. THE PHYSICIAN PLANNED TO HAVE THE PATIENT RETURN TO THE CLINIC SOON TO RETAKE IMPEDANCES. IT WAS NOTED NO LESION WAS CONFIRMED. THE PHYSICIAN NOTED THE ¿POSSIBILITY OF LESSENED TREMOR UPON EXAMINATION, BUT THE REASON HAD NOT BEEN IDENTIFIED.¿ IT WAS NOTED THE PHYSICIAN MAY ORDER AN MRI DEPENDING ON THE OUTCOME OF AN ADDITIONAL PATIENT EVALUATION AND IMPEDANCE TESTING. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245931 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other