BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4132603 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18084
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 9, 2014
    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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TWO TO THREE DAYS PRIOR TO REPORT THE PATIENT HAD WORKED IN HIS SHOP AND LEANED OVER TWO 12V BOAT BATTERIES AND HAD USED AN ELECTRIC COMPRESSED NAIL GUN AND SKILL SAW. THE PATIENT HAD AN EPISODE TWO DAYS PRIOR TO REPORT THAT WAS ¿VERY UNUSUAL¿. THE PATIENT HAD NOTICED HE WAS NOT FEELING WELL AND WHEN THEY CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) IT SHOWED THAT IT WAS OFF. FIVE MINUTES AFTER THEY TURNED THE INS BACK ON THE PATIENT STARTED TO FEEL MUCH BETTER. THE DOCTOR HAD CHECKED THE PATIENT¿S DEVICE ON THE DAY OF REPORT AND THE IMPEDANCES WERE NORMAL. DAILY USE SHOWED THE INS HAD BEEN OFF PART OF SATURDAY AND MOST OF SUNDAY PRIOR TO REPORT. NO POWER ON RESET (POR) OR OTHER ERRORS WERE PRESENT UPON INTERROGATION. TWO DAYS PRIOR TO REPORT THE PATIENT NOTICED THAT THEIR PROGRAMMER STARTED TO SHOW ONLY ICONS INSTEAD OF TEXT UNEXPECTEDLY AND THEY WERE UNSURE HOW TO GET THE TEXT BACK ON THE SCREEN. THE PATIENT¿S INS WAS ON AND THE THERAPY WAS WORKING AND THE EPISODE WAS RESOLVED. THEY WERE ABLE TO PUT THE PROGRAMMER BACK INTO TEXT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610130 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR