BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3430303 · Received October 25, 2013

    Report

    Report Number
    3004209178-2013-19691
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Report Date
    October 10, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 387S-40, LOT# V053450, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V055601, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT HAD NUMBNESS IN THEIR HEAD SPREADING ALL THE WAY DOWN THE RIGHT SIDE TO THEIR LEG. IT WAS NOTED THE PATIENT'S RIGHT EYE WAS DROOPING. THE REPORTER STATED THIS STARTED TWO WEEKS AGO. IT WAS NOTED THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) CHANGED THE PATIENT'S PROGRAM FROM A TO B. THE REPORTER STATED THAT PROGRAM B WAS NOT MANAGING THE PATIENT'S SYMPTOMS. IT WAS NOTED THAT WHEN THE PATIENT TURNED DOWN STIMULATION ON PROGRAM A THE SIDE EFFECTS WENT AWAY, BUT THEIR SYMPTOMS WERE NOT MANAGED AS WELL. THE REPORTER STATED THE PATIENT WAS NOT "QUITE AS GOOD" SINCE THEIR INS REPLACEMENT ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE WAS ON THEIR WAY TO MEET WITH THE PATIENT. THE REPORTER STATED THEY WERE NOTIFIED BY THE PATIENT'S HCP THIS PAST FRIDAY. THE REPORTER FURTHER STATED THE HCP REPORTED AN IMPEDANCE ISSUE, SOME HIGH AND LOW. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT AND THE PATIENT SEEMED TO HAVE INADVERTENTLY TURNED THE AMPLITUDE UP TOO FAR. IT WAS NOTED THAT IMPEDANCE WAS DONE THREE WEEKS AGO AND CONTACT 2 AND 3 ON THE LEFT SIDE WERE AT 87 OHMS. IT WAS FURTHER NOTED THAT ON THE DAY OF THIS REPORT IMPEDANCES WERE WITHIN NORMAL RANGE. IT WAS NOTED THAT CONTACTS 2 AND 3 ON THE LEFT SIDE WERE NOT BEING USED IN PROGRAMMING. THE REPORTER STATED THAT AFTER TURNING DOWN THE AMPLITUDE TO AN ACCEPTABLE LEVEL, THEY WERE UNABLE TO REPLICATE ANY OF THE ALLEGED SIDE EFFECTS SUCH AS SHOCKING SO PROGRAMMING RESOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SEEN IN THE CLINIC THE MORNING OF THIS REPORT. THE REPORTER STATED THEY WERE UNABLE TO ELICIT THE SAME SIDE EFFECTS THAT THE PATIENT PREVIOUSLY EXPERIENCED. IT WAS NOTED A MONO-POLAR REVIEW WAS DONE AND NO PROBLEMS WITH ANY CONTACTS WERE FOUND. IT WAS FURTHER NOTED THAT IMPEDANCES WERE WITHIN THE NORMAL RANGE. THE REPORTER STATED THERE WERE NO SIDE EFFECTS NOTED UPON PALPATION OF THE INS AND ADAPTOR. IT WAS NOTED THE PATIENT WAS REPROGRAMMED TO THEIR INITIAL SETTINGS AND SEEMED TO BE GETTING ADEQUATE THERAPY WITHOUT SIDE EFFECTS. THE REPORTER STATED THE PATIENT WOULD RETURN TO THE CLINIC AT THE END OF THE DAY TO MAKE SURE THE SIDE EFFECTS HAD NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548117 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR