BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5367219 · Received January 14, 2016

    Report

    Report Number
    3004209178-2016-00553
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 22, 2015
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONSUMER AND HEALTH CARE PROVIDER (HCP) REPORTED THEY HAD NEW SUDDEN INTERMITTENT SYMPTOMS OF MUSCLE TWITCHING AND PULLING AND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PATIENT HAD TWITCHING OF THEIR RIGHT PECTORAL MUSCLE THAT WAS POSITION RELATED AND ONLY OCCURRED WHEN STIMULATION WAS ON AND THEIR ARM WAS ABDUCTED. THE SYMPTOMS STARTED ON (B)(6) 2015. THE PATIENT TRIED TURNING THE INS OFF TO SEE IF THE SYMPTOMS RESOLVED. THE SYMPTOMS HAD RESOLVED WHEN THE INS WAS TURNED OFF, BUT THE SYMPTOMS HAPPENED TWICE ON (B)(6) 2015 AFTER THE INS WAS TURNED BACK ON. THE INS WAS PROGRAMMED AT A RATE OF 70 HZ AND THE TWITCHING OCCURRED AT ABOUT 1 TWITCH PER SECOND. THE PATIENT DID NOT FEEL ANY SHOCKING OR OTHER STIMULATION SENSATIONS ALONG THE LEAD. THERE WERE NO FALLS, TRAUMA, OR ENVIRONMENTAL EXPOSURE, BUT THE PATIENT'S CHILD HAS HIT THEIR HEAD AGAINST THEIR CHEST AREA. IMPEDANCES WERE CHECKED BY THE HCP AND THERE WAS A CHANGE IN THERAPY IMPEDANCES. NORMAL IMPEDANCES WERE 645 OHMS, BUT THE IMPEDANCES CHANGED TO 840-890 OHMS WHEN THE PATIENT WAS IN THE POSITION THAT CAUSED THE TWITCHING. THERE WAS NOTHING UNUSUAL NOTED WHEN ELECTRODE IMPEDANCES WERE CHECKED, BUT MO NOPOLAR IMPEDANCES WERE AS HIGH AS 2100-2300 OHMS. THERAPY WAS PROGRAMMED USING C-3 AND THE IMPEDANCE OF THAT COMBINATION WAS 746 OHMS. THE PATIENT TRIED CONTACTING THEIR HCP AND THEIR FIRST AVAILABLE APPOINTMENT AS IN (B)(6) 2016. THE HCP WAS GOING TO HAVE A SURGEON LOOK AT THE SYSTEM TO TRY TO FIND THE ISSUE. THE PATIENT'S INDICATION FOR USE IS DYSTONIA AND MOVEMENT DISORDERS. NO ACTIONS/INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25879 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR