BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2690479 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06744
    Event Type
    Injury
    Date Received
    August 10, 2012
    Report Date
    July 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    PRODUCT ID 37085-60, LOT#, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37085-60, LOT#, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3389S-40, LOT# V813627, SERIAL# IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3389S-40, LOT# V813627, SERIAL# IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD LOW OUT-OF-RANGE IMPEDANCE VALUE. THE PATIENT WAS BEING SEEN IN PRE-OP AND THE BATTERY HAD BEEN DRAINING QUICKLY. THE DEVICE BATTERY WAS 2.9V AFTER 7 MONTHS OF IMPLANT. LONGEVITY CALCULATION PERFORMED BASED ON THE FOLLOWING SETTINGS: LEFT = 2.6V,PW OF 60, 130 HZ, 3+,2- WITH THERAPY IMPEDANCE OF 149 OHMS AND RIGHT = 2.5V, PW OF 60 US, 130 HZ, 10-,11+ WITH THERAPY IMPEDANCE OF 2392 OHMS, FOUND ERI (ELECTIVE REPLACEMENT INDICATOR) = 23.15 MONTHS AND EOS (END OF SERVICE) = 2.18 YEARS. IT WAS REPORTED THAT THE ELECTRODE IMPEDANCES WERE NORMAL. AT 1.5V THERE WERE SOME PAIRS READING >5000, BUT WHEN TESTED AT 3.0V THERE WERE NO OUT-OF-RANGE RESULTS. THE PATIENT WAS GETTING THERAPEUTIC BENEFIT BUT WAS HAVING CHALLENGES RECENTLY. THE PATIENT WAS GOING IN FOR REVISION NOW TO CHANGE OUT THE DEVICE AND TEST IMPEDANCES WITH RESPECT TO POSSIBLE SHORT CIRCUIT DUE TO LOW THERAPY IMPEDANCE FOR LEFT SIDE. IT WAS ALSO REPORTED THAT THE PATIENT SAW AN ERI MESSAGE ON THE PATIENT PROGRAMMER, WHICH WAS ALSO BEING SEEN TODAY, BUT THE BATTERY VOLTAGE WAS 2.9. THE DEVICE HAD BEEN OFF FOR MONTHS UNTIL THEY HAD DETERMINED WHAT WAS GOING ON. IT WAS REPORTED THE PATIENT HAD FALLEN MORE THAN ONCE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCE IMPROVED BY CHANGING/REPLACING THE EXTENSIONS AND BATTERY. NO PATIENT OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention