BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3813621 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09056
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L70665, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# L77014, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(6): PROGRESSIVE ONSET THAT STARTED OVER 6 MONTHS PRIOR TO REPORT. IT WAS NOTED THE LAST MONTH PRIOR TO REPORT HAD BEEN THE WORST. IT WAS NOTED THE PATIENT HAD SYMPTOMS ON THEIR RIGHT SIDE. IT WAS STATED THE THERAPY IMPEDANCE ON BOTH IMPLANTABLE NEUROSTIMULATORS (INS) READ VERY SIMILAR IN TERMS OF OHMS VALUE. IT WAS NOTED NEITHER INS LOOKED SUSPICIOUS IN REGARDS TO IMPEDANCE. IT WAS STATED THE PATIENT¿S SYMPTOMS WERE MORE NOTICEABLE. IT WAS STATED THEY HAD DYSARTHRIA, FACIAL PULLING, VOICE, AND ¿FACE EYES¿ THAT WERE ON THE RIGHT SIDE OF THE BODY. IT WAS NOTED THE PATIENT HAD SCOLIOSIS BUT THE PATIENT WAS MOBILE. IT WAS STATED ALL ELECTRODE IMPEDANCES WERE REPORTED TO BE NORMAL EXPECT C0 AT 2,942 OHMS SHOWED HIGH ON THE RIGHT INS. IT WAS NOTED THERE WAS AN AMPLITUDE TITRATION HISTORY FOR THE INS ON THE PATIENT¿S RIGHT SIDE OF THEIR BODY. IT WAS STATED ON (B)(6) 2014 THEY WERE AT 2.8V, ON (B)(6) 2014THEY WERE AT 3.3V, AND ON THE DAY OF REPORT THEY WERE AT 3.1V. IT WAS STATED THE LEFT INS HAD HIGH IMPEDANCE OF >200 0 OHMS. IT WAS NOTED 0 ELECTRODE APPEARED TO BE ¿TRUE OPEN.¿ IT WAS STATED A LONGEVITY ESTIMATE WAS CALCULATED OF 5 YEARS AND 6 MONTHS. IT WAS NOTED THE PATIENT STILL HAD 6-12 MONTHS UNTIL EXPECTED DEPLETION. IT WAS STATED THE PATIENT¿S SYMPTOMS WOULD COME AND GO AND IT APPEARED TO OCCUR WITH THE MOVEMENT OF THE LEFT ARM. IT WAS STATED IT APPEARED TO CAUSE STIMULATION RELATED SIDE EFFECTS. IT WAS FURTHER REPORTED THE NEUROLOGIST AND THE MANUFACTURER REPRESENTATIVE HAD CONDUCTED SEPARATE IMPEDANCE TESTS AND THEY SAW NOTHIING THAT INDICATED THAT THE DEVICE WASN¿T WORKING. IT WAS NOTED NO MALFUNCTIONS WERE SEEN AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS STATED THE VOLTAGES WERE INCREASED BY THE NEUROLOGIST. IT WAS STATED THE PATIENT APPEARED TO EXPERIENCE WORSE SYMPTOMS ASSOCIATED WITH PROGRESSION OF THE DISEASE AND NOT OF STIMULATION-RELATED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291120 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR