BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4794375 · Received May 26, 2015

    Report

    Report Number
    3004209178-2015-09621
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389S-40, LOT# V247063, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V250050, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LONGEVITY CALCULATION WAS DONE TO ESTIMATE THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE AND THERE WERE OUT OF RANGE IMPEDANCE VALUES. DEVICE SETTINGS WERE C+3-2-1-, 3.5V, 60 PULSE WIDTH, 180 RATE, 920 OHMS AND LONGEVITY ESTIMATED ELECTIVE REPLACEMENT INDICATOR (ERI) AT 2.98 AND END OF SERVICE (EOS) AT 3.23. C1 WAS GREATER THAN 40,000, C/0-1503, C/2-1391, C/3-1377. ANY BIPOLES AGAINST CASE WERE GREATER THAN 40,000, 2/3 WAS 1609. THE GREATER THAN 40,000 HAD SHOWED UP FOR THE FIRST TIME ON THE DATE OF THIS REPORT. THE LAST CHECK HAD BEEN IN (B)(6) PRIOR TO THE DATE OF THIS REPORT AND IT WAS 1629 AT THAT TIME. THE OTHER INS HAD NO ISSUES WITH IMPEDANCES; DEVICE SETTINGS WERE C+3-2-1-, 4V, 60 PULSE WIDTH, 170 RATE, 667 OHMS WITH ERI AT 2.1 YEARS AND EOS AT 2.35 YEARS. THEY WERE GOING TO OBTAIN X-RAYS AND HAD CONTEMPLATED REPLACEMENT THE INS THAT WAS NOT HAVING IMPEDANCE ISSUES. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338426 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR