BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3388545 · Received October 4, 2013

    Report

    Report Number
    3004209178-2013-17514
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    May 20, 2013
    Report Date
    September 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-09, LOT# LC4456, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3389-40, LOT# J0454231V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V062549, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SEEMED TO GO THROUGH HER BATTERIES VERY QUICKLY. THE REPORTER STATED THAT THEY HAD IDENTIFIED WHAT LOOKED TO BE A SHORT BETWEEN CONTACTS 4 AND 6 ON THE RIGHT SIDE; IT WAS AT 59 OHMS. THE REPORTER NOTED THAT THE PATIENT WAS USING CONTACTS 4 AND 5 AND THE THERAPY IMPEDANCE WAS AT 488 OHMS AND 8.457 CURRENT. THE REPORTER CONFIRMED THAT THE PATIENT'S THERAPY WAS OKAY. THE REPORTER MENTIONED THAT CONTACTS 5 AND 7 SHOWED 1,202 OHMS, SO HE MAY TRY USING THAT CONTACT TO SEE IF THERAPY WAS GOOD AND IF LONGEVITY COULD BE INCREASED. THE PATIENT WAS AT 2.65 VOLTS FOR BATTERY VOLTAGE AT THE TIME OF THE REPORT. A LONGEVITY CALCULATION WAS PERFORMED USING THE GIVEN PARAMETERS AND AN IMPEDANCE OF 1,210 OHMS AND CAME BACK AS APPROXIMATELY 16.5 MONTHS FOR ELECTIVE REPLACEMENT INDICATOR (ERI) AND APPROXIMATELY 20 MONTHS FOR END OF SERVICE (EOS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN IMPLANTABLE NEUROSTIMULATOR REPLACEMENT THE PATIENT STILL HAD A SHORT BETWEEN ELECTRODES 4 AND 6. IT WAS LATER REPORTED THAT THE PATIENT WAS GETTING FINE THERAPY AT THE TIME. THE PATIENT WAS PROGRAMMED USING ELECTRODES 4 (NEGATIVE) AND 5 (POSITIVE). PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2013-08309 FOR THE SHORT CIRCUIT ON THE PREVIOUS IMPLANTABLE NEUROSTIMULATOR. IMPEDANCE OF OTHER COMBINATION ELECTRODE PAIRS WERE AS FOLLOWS: #4 TO #6 = 63 OHMS; #4 TO #5 = 501 OHMS; #5 TO #7 = 1261 OHMS; #5 TO #6 = 497 OHMS; #6 TO #7 = 1027 OHMS; CASE TO #5 = 694 OHMS; CASE TO #4 = 541 OHMS, CASE TO #6 = 541 OHMS; CASE TO #7 = 1091 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504957 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR