BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3231711 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11896
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER; PHYSICIAN PRODUCT ID 64002, LOT# N221066, IMPLANTED: (B)(6) 2010: PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V079085, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V079085, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL USING THE CONSTANT VOLTAGE SETTING. THERE WERE NO NEW FINDINGS SINCE THE LAST REPORT. THE CLINICIAN PROGRAMMER WAS NOT SUSPECTED TO BE THE CAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO PROGRAMS: CURRENT MODE AND VOLTAGE MODE. IT WAS NOTED THAT THE CLINICIAN PROGRAMMER COULD DECREASE CURRENT BUT COULD NOT INCREASE THE CURRENT IN CURRENT MODE. VOLTAGE COULD BE ADJUSTED AS NORMAL. WHEN THE PATIENT PROGRAMMER WAS USED CURRENT COULD BE INCREASED AND DECREASED. IT WAS NOTED THAT THE VALUES WERE GRAYED OUT ON THE CLINICIAN PROGRAMMER WHICH PREVENTED INCREASING THE CURRENT. IT WAS FURTHER NOTED THERE WERE NO ERROR OR CHARGE DENSITY MESSAGES. THE PATIENT WAS RECEIVING THERAPY. THERAPY IMPEDANCES WERE NORMAL. THE PROGRAMMED SETTINGS WERE UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE HAD BEEN "NO LAPSE IN THERAPY AT ALL." IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED TO MEET WITH THE HEALTHCARE PROFESSIONAL (HCP) AND MANUFACTURING REPRESENTATIVE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS GOOD THERAPY WITH BOTH THE LEFT AND RIGHT IMPLANTABLE NEUROSTIMULATOR (INS). THE LEFT INS WAS PROGRAMMED IN VOLTAGE MODE AND THE RIGHT WAS PROGRAMMED IN CURRENT MODE. THE LEFT INS THAT WAS IN VOLTAGE MODE HAD NO ISSUES, HOWEVER, WHEN THE RIGHT INS WHEN DECREASED WITH THE CLINICIAN PROGRAMMER, IT COULD NOT BE INCREASED AGAIN AND AN OUT OF REGULATION (OOR) MESSAGE WOULD BE DISPLAYED ON THE CLINICIAN PROGRAMMER. THE PATIENT PROGRAMMER WAS THEN USED TO INCREASE THE SETTING. THE CLINICIAN PROGRAMMER WOULD BE RECHECKED AND IT WOULD INDICATE THE CORRECT SETTING WITHOUT THE OOR MESSAGE. LATER THE ISSUE REOCCURRED. IMPEDANCE ON THE RIGHT SIDE WAS MEASURED AT: C/4 1320, C/5 2387, /6 1282, C/7 1190, 4/5 2000, 4/6 1734, 4/7 1849, 5/6 1989, 5/7 2608, 6/7 1435. THE CLINICIAN PROGRAMMER WAS TURNED ON AND OFF BUT IT "MADE NO DIFFERENCE." IT WAS NOTED THAT THE PATIENT EXPERIENCED "INTERMITTENT ZAPPING" BUT ONLY WHILE RECHARGING. THE PATIENT WAS 75% CHARGED. IT WAS NOTED THE DEVICE WAS "TOPPED OFF" EVERY NIGHT AND "DROPPED THE CHARGE" QUICKLY. THERE WAS A POSSIBLE OPEN CIRCUIT ON C/5. IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED ON C/4 AND THE ISSUE WENT AWAY. THERE WAS NO OOR ON THE CLINICIAN PROGRAMMER WHEN INCREASING THE SETTING. IMPEDANCES WERE MEASURED ON THE LEFT INS AND A VALUE OF OVER 10,000 OHMS WAS OBSERVED ON ELECTRODE TWO. IT WAS NOTED THERE WAS AN OPEN CIRCUIT ON ELECTRODE TWO. IT WAS NOTED THAT ELECTRODE TWO WAS NOT USED FOR THERAPY. ADDITIONAL INFORMATION REPORTED OOR WAS DUE TO HIGHER IMPEDANCES AND THE DEVICE NOT BEING ABLE TO DELIVER THE CURRENT DRAW REQUIRED BY SETTINGS. A FOLLOW UP APPOINTMENT WAS SET FOR LATER THE WEEK OF REPORT AND THE PATIENT WAS ON "CV": MODE WITH TEMPORARILY RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332346 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR