BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2914426 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00570
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 24, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # V296972, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED FACIAL PULLING AND TWITCHING OF THE RIGHT ARM. IT WAS NOTED THAT THE DEVICE WAS ON THE LEFT SIDE. IT WAS REPORTED THAT THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A FALL. THE REPORTER STATED THAT THE PATIENT HAD A "VERY BAD FALL" ABOUT TWO MONTHS PRIOR TO THE REPORT AND ANOTHER FALL TWO DAYS BEFORE THE REPORT. IT WAS NOTED THAT THE LAST DEVICE PROGRAMMING SESSION WAS 17 DAYS BEFORE THE REPORT, AND SYMPTOMS BEGAN THE DAY OF THE REPORT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DEVICE WAS ON. THE REPORTER STATED THAT AN "LCC" WAS USED AND THE RESULTS WERE "4 OK." IT WAS BELIEVED THAT LCC REFERRED TO A LEAD CONNECTION CHECK AND "4 OK" REFERRED TO THE ELECTRODES. IT WAS NOTED THAT THE CURRENT IMPEDANCE MEASUREMENTS ACCORDING TO THE LCC WERE NORMAL. THE REPORTER STATED THAT IT WAS BELIEVED THAT NO PROGRAMMING CHANGES WERE MADE AT THE LAST REPROGRAMMING SESSION, BUT THE PATIENT'S MEDICATIONS WERE TITRATED DOWN. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING INCREASED TREMOR SINCE THE FALL ABOUT TWO MONTHS AGO, SO THE REPORTER WAS "SKEPTICAL ABOUT THE MEDICATION REDUCTION." IT WAS REPORTED THAT THE PATIENT WAS DIRECTED TO TAKE 0.5 TABLE OF SINEMET, BUT TOOK A WHOLE ONE THE NIGHT PRIOR TO THE REPORT AND THE MORNING OF THE REPORT. IT WAS ADDITIONALLY REPORTED THAT THE THERAPY IMPEDANCE "READ HIGH." THE REPORTER STATED THAT IMPEDANCES WERE GREATER THAN 20,000 OHMS. IT WAS NOTED THAT THE PATIENT WOULD BE SEEING THE PHYSICIAN THE NEXT DAY. TWO WEEKS LATER, IT WAS REPORTED THAT IMPEDANCE TESTING HAD BEEN PERFORMED WITH A CLINICIAN PROGRAMMER AND IMPEDANCES WERE "FAIRLY HIGH." IT WAS NOTED THAT IMPEDANCES ON THIS PATIENT WERE "HIGH PREVIOUSLY" AS WELL. THE REPORTER STATED THAT THE PATIENT WAS TRYING TO SCHEDULE AN APPOINTMENT WITH HER NEUROLOGIST. IT WAS REPORTED THAT TWO DAYS AFTER THE EVENT THE PATIENT WAS "DOING OK." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20034 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization