BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4081849 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16822
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 20, 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 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 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# VA01UJ1, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT IMPEDANCES HAD BEEN FINE IN (B)(6) 2013 BUT WHEN THE PATIENT WAS SEEN IN (B)(6) 2013 THE ISSUE WAS NOTICED. THERE WERE LOW OUT OF RANGE IMPEDANCES. THE PATIENT¿S TWO LEADS IN THEIR VENTRAL INTERMEDIATE NUCLEUS (VIM) WERE VERY CLOSE TOGETHER. THE PATIENT HAD BEEN SEEN 2 WEEKS PRIOR TO THE DATE OF THIS REPORT IN THE CLINIC. THE LEFT VIM LEAD WAS NUMBERED 8-11. IMPEDANCE READINGS WERE C/8-3036, C/9-983, C/10-986, C/11-3673, 8/9-3153, 8/10-3118, 8/11-6752, 9/10-31, 9/11-3711 AND 10/11-3673. THE PATIENT WAS PROGRAMMED AT C+9-, 2V, 60PW, 130R AND THERAPY IMPEDANCE WAS 820 AND 2.791. THERE WERE NO FALLS OR TRAUMAS. THE PATIENT HAD A BOTOX INJECTION IN (B)(6) 2013. THE PATIENT¿S RIGHT LEG WEAKNESS HAD BEEN EXACERBATED. THE PATIENT HAD BEEN AT THE SAME CONTACTS FOR 1.5 YEARS PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THEY WERE LABELED LEFT VIM FOR (B)(6) 2012 AND THE RIGHT VIM FOR (B)(6) 2011. LOW IMPEDANCES HAD NOT RESOLVED. THE CAUSE OF THE IMPEDANCE WAS UNKNOWN AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE SHORT HAD BEEN NOTICED AT RECENT PROGRAMMING VISIT ON THE NEWEST DEEP BRAIN STIMULATOR VIM LEAD. IT HAD STARTED BETWEEN (B)(6) 2013 AND (B)(6) 2013 BUT HAD BEEN NOTICED ON (B)(6) 2014. NO FURTHER TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS HAD BEEN TAKEN BUT THEY COULD CONSIDER X-RAYS, (B)(6) 2014. PATIENT OUTCOME WAS UNKNOWN. SINCE #9 WAS BEING USED ON THAT LEAD PROGRAMMING WAS CHANGED TO C+8- SO THEY WOULD NOT ¿RECRUIT¿ #10. THE PATIENT WAS HAVING MORE RIGHT LEG WEAKNESS THAN HER BASELINE SINCE 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560878 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR