BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4631930 · Received March 25, 2015

    Report

    Report Number
    3004209178-2015-05372
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Report Date
    March 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0JQGE, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD PRODUCT ID: 3389S-40, LOT# VA0KSWZ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS DISPLAYING A ¿CALL YOUR DOCTOR¿ ICON AND AN OUT OF REGULATION (OOR) CONDITION. THE PATIENT HAD GONE TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) PRIOR TO THE DATE OF THIS REPORT AND HAD SEEN THE OOR MESSAGE. (B)(6) HAD BEEN THE FIRST TIME THE PATIENT HAD USED THE PROGRAMMER IN ABOUT A WEEK AND A HALF. THE PATIENT WAS DOING FINE, ON THE LEFT SIDE HE COULD GO UP TO 6V BUT HAD IT AT 5.5 AND HE NEVER TOUCHES THE RIGHT SIDE. THE PATIENT HAD CALLED HIS HEALTHCARE PROFESSIONAL WHEN THE MESSAGE WAS SEEN BUT HAD NOT HEARD FURTHER FROM THE HEALTHCARE PROFESSIONAL. THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE INS WAS FUNCTIONING FINE PER HEALTHCARE PROFESSIONAL¿S EVALUATION BUT THE PATIENT PROGRAMMER HAD BEEN SHOWING OOR SINCE (B)(6) 2015. THE PATIENT WAS UNABLE TO TURN STIMULATION UP USING THE PATIENT PROGRAMMER AND NEITHER WAS THE HEALTHCARE PROFESSIONAL. IMPEDANCES WERE EVALUATED AND HAD APPEARED TO HAVE SPIKED ON THE LEFT SIDE SINCE (B)(6) PRIOR TO THE DATE OF THIS REPORT. PATIENT¿S PROGRAMMED VALUES WERE 5.5MA, 185HZ, 60 USEC AND 2.5, 185HZ, AND 60USEC FOR THE OTHER SIDE. IMPEDANCE VALUES FROM THE DATE OF THIS REPORT ON THE LEFT SIDE WERE C/0-3619, C/1-1304, C/2-2734, C/3-1304, 0/1-3842, 0/2-6321, 0/3-4084, 1/2-3208, 1/3-2098 AND 2/3-3188. FOR THE RIGHT SIDE THEY WERE C/8-1626, C/9-1564, C/10-1143, C/11-1626, 8/9-1831, 8/10-1903, 8/11-2495, 9/10-1502, 9/11-2192 AND 10/11-1564. THERAPY IMPEDANCE FOR THE LEFT WAS XXX XXX AND RIGHT SUBTHALAMIC NUCLEUS WAS 963 OHMS 2.483MA. ON (B)(6) LEFT SIDE IMPEDANCE HAD BEEN C/0-1589, C/1-1221, C/2-1259, C/3-1332, 0/1-2246, 0/2-2474, 0/3-2391, 1/2-1912, 1/3-2151 AND 2/3-2051. NO OUTCOME OR INTERVENTION WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT PROGRAMMER WAS THE COMPONENT INVOLVED IN THE EVENT. THE PATIENT WAS NO LONGER ABLE TO CHANGE PROGRAMS OR AMPLITUDE. REPROGRAMMING WAS REQUIRED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD HAD AN APPOINTMENT ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198687 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR