BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3223745 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11679
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010: PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010: PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V484000, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V484000, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT BEEN SEEN IN THE DOCTOR¿S OFFICE SINCE 2008. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND SAW A POOR COMMUNICATION SCREEN. IT WAS NOTED A ¿CALL YOUR DOCTOR¿ ICON AND OUT OF REGULATION (OOR) MESSAGE WAS DISPLAYED. THE REPORTER STATED THE MESSAGE APPEARED ON THEIR PATIENT PROGRAMMER DURING THE WEEK PRIOR TO THIS REPORT. IT WAS NOTED THE PATIENT WAS REPROGRAMMED ¿ABOUT TWO AND A HALF WEEKS¿ PRIOR TO THIS REPORT AND HAD BEEN ABLE TO USE THE PATIENT PROGRAMMER SINCE. IT WAS FURTHER NOTED THE PATIENT WAS UNSURE IF THEY TRIED TO INCREASE OR DECREASE STIMULATION WHEN THE MESSAGE APPEARED. THE REPORTER STATED THEY WERE ABLE TO BYPASS THE OOR MESSAGE AND THEN SAW ¿ON AND OK.¿ IT WAS NOTED THE PATIENT WAS ON PROGRAM A AND WANTED TO TRY PROGRAM B. IT WAS FURTHER NOTED WHEN THE PATIENT WAS ON PROGRAM A THEY STARTED TO FEEL ¿TWITCHING¿ AGAIN. IT WAS REPORTED THAT THE DEVICE WAS CHANGED FROM PROGRAM A TO PROGRAM B, AND THE PATIENT STARTED TO ¿SHAKE A LITTLE BIT.¿ THE REPORTER STATED THEY WOULD KEEP THE IMPLANTABLE NEUROSTIMULATOR ON PROGRAM B FOR NOW. IT WAS NOTED THE THERAPY WAS HELPING BY 70-80%, BUT THE PATIENT WAS ¿STRIVING FOR PERFECTION.¿ IT WAS NOTED THE PATIENT GOT A LOT OF TWITCHING IN THEIR NECK AND LEFT SHOULDER AFTER THE PATIENT WAS REPROGRAMMED. IT WAS FURTHER NOTED FOR THE PAST 4-5 MONTHS PRIOR TO THIS REPORT THE PATIENT HAD A LOT OF PAIN IN THEIR NECK. THE REPORTER STATED THEY WERE TAKING BOTOX AND ONCE THE BOTOX WORE OFF THEY WOULD GO BACK TO THEIR HEALTHCARE PROFESSIONAL WHERE THEY WILL ¿ZERO HIM OUT AND START FRESH.¿ IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HIS DOCTOR OR MANUFACTURER REPRESENTATIVE AND HIS CONCERNS WERE RESOLVED, AND THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013 AND HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. IT WAS NOTED THAT CONTACT #11 WAS NOT WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324092 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR