BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4664436 · Received April 7, 2015

    Report

    Report Number
    3004209178-2015-06050
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 17, 2015
    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
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 387S-40, LOT # V020186 , IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD FELT KIND OF SLUGGISH YESTERDAY AND THE DAY OF THIS REPORT. THE REPORTER WAS GOING TO CHANGE THE PATIENT¿S SETTINGS TODAY. THE PATIENT SEEMED LESS SLUGGISH AND IT SEEMED TO HELP WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF AND THEN BACK ON. WHEN THE REPORTER WENT TO USE THE PATIENT PROGRAMMER THEY SAW A FLASHING WARNING SCREEN ICON LOCATED NEXT TO THE INS BATTERY LEVEL ICON. THE REPORTER FIRST SAW THE FLASHING WARNING ICON ONE DAY LAST WEEK OR THIS PAST SUNDAY. AT THE TIME OF THIS REPORT, THE REPORTER SAW THE WARNING ICON AND 2.61V WHEN THEY CHECKED THE INS. AFTER THE PATIENT CHANGED THE PROGRAMMER SETTINGS TO LETTER MODE, AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS DISPLAYED. THE REPORTER HAD CONTACTED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) THE MORNING OF THIS REPORT. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THEIR HCP FOR (B)(6) 2015. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS NORMAL AND THE INS HAD NOT BEEN EXPLANTED OR REPLACED. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229904 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR