BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2913007 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00505
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    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 PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V641090, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V641090, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT THE DOCTOR'S OFFICE FOR REPROGRAMMING THE DEVICE AND TO TURN IT UP TO THREE VOLTS. THE REPORTER STATED THAT THE PATIENT WAS DOING WELL AND THE BATTERY LEVEL WAS AT 2.89 VOLTS. IT WAS REPORTED THAT WHEN THE DEVICE WAS INTERROGATED WITH THE PATIENT PROGRAMMER AN ERI (ELECTIVE REPLACEMENT INDICATOR) POPPED UP. IT WAS NOTED THAT ERI WAS SUPPOSED TO TRIGGER AT 2.6 VOLTS. THE REPORTER STATED THAT THE PATIENT WASN'T HAVING THERAPY PROBLEMS. IT WAS NOTED THAT THE FIRST DAY THEY HAD SEEN ERI WAS THE DAY OF THE REPORT. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) CONFIRMED THE ERI MESSAGE ON THE PATIENT PROGRAMMER AND DID NOT KNOW IF THERE HAD HISTORICALLY BEEN ANY SHORTS IN THE ELECTRODE IMPEDANCES. IT WAS NOTED THAT THE HCP WAS THINKING ABOUT REPLACING THE DEVICE. TWO WEEKS LATER, IT WAS REPORTED THAT NO ACTION WAS TAKEN. THE DEVICE VOLTAGE WAS AT 2.89 VOLTS AND THE PHYSICIAN DECIDED NOT TO REPLACE THE DEVICE. IT WAS NOTED THAT THE PATIENT WAS STILL RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20144 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1