BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3854392 · Received June 6, 2014

    Report

    Report Number
    3007566237-2014-01562
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 37602, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OUT OF RANGE (OOR) MESSAGE WAS DISPLAYED ON THE PATIENT PROGRAMMER WHEN TELEMETRY WAS PERFORMED ON THE PATIENT¿S RIGHT IMPLANTABLE NEUROSTIMULATOR (INS). THE OOR CLEARED WHEN THE STIMULATION SETTINGS WERE REPROGRAMMED TO CHANGE THE MAXIMUM AND MINIMUM VOLTAGE PARAMETERS, BUT RETURNED ON (B)(6) 2014 WHEN THE PATIENT WAS AT THE CLINIC. ANOTHER OOR WAS DISPLAYED TWO DAYS LATER. IT WAS REPORTED THERE WAS NO HEALTH HAZARD TO THE PATIENT. TELEMETRY DATA SHOWED HIGH IMPEDANCES ON CONTACT 0 ON THE RIGHT SIDE. IMPEDANCES (OHMS) WERE AS FOLLOWS: C<(>&<)>0: 10738, 0<(>&<)>1: 11041, 0<(>&<)>2: 11362, 0 <(>&<)>3: 11403. ALL OTHER IMPEDANCES WERE WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS IMPLANTED WITH THE RIGHT INS ON (B)(6) 2014. ON (B)(6) 2014, THE OOR MESSAGE WAS SEEN BY THE FOLLOW UP PHYSICIAN. STIMULATION PARAMETERS WERE ADJUSTED AND THE OOR WAS NO LONGER DISPLAYED AT THE CLINIC, BUT REAPPEARED AT THE PATIENT¿S HOME. THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT AND PHYSICIAN AND CONFIRMED THE OOR ON (B)(6) 2014. IT WAS THEN THAT THE HIGH IMPEDANCES WERE OBSERVED ON CONTACT 0. THE RANGE OF ¿MANAGEABLE¿ OUTPUT WAS CHANGED FROM 1.0 V TO 0.8 V AND THE OOR DISAPPEARED. IT WAS NOTED THAT THE PATIENT USES THE SAME STIMULATION PARAMETERS ON BOTH INSS, BUT THEY ONLY HAD THE OOR ON THE RIGHT INS. CONTACT 0 WAS NOT BEING USED FOR THE PATIENT¿S THERAPY. ADDITIONAL INFORMATION CLARIFIED THAT THE PATIENT SAW THE OOR WHEN THEY TRIED TO INCREASE VOLTAGE. THE PATIENT WAS ONLY USING THEIR PROGRAMMER 2-3 TIMES PER WEEK. THE PATIENT HAD NOT SEEN THE OOR MESSAGE SINCE MEETING WITH THE REPRESENTATIVE. FURTHER INFORMATION INDICATED FOLLOW UP WAS ONGOING, BUT THE ¿THERAPY IS PROPERLY IMPLEMENTED.¿

    Description of Event or Problem · 1

    IT WAS CONSIDERED THAT THERE WERE NO PARTICULAR ISSUES WITH THE REMAINING BATTERY, POSSIBILITY OF SHORT CIRCUITS OF THE ELECTRODES BEING USED OR THE STIMULUS SETTINGS BUT THE CAUSE OF THE OOR WAS UNKNOWN. WHEN AN OOR DISPLAYED, IT WAS RESOLVED BY RE-SETTING OF THE UPPER AND LOWER VALUES WITH THE PATIENT PROGRAMMER, WHICH THE PATIENT PROGRAMMED HIMSELF. THERE WERE NO MAJOR CHANGES IN THE STIMULUS SETTINGS IN EITHER SIDE; IT WAS OPERATING THE CHANGEABLE MODE THE PATIENT COULD CONTROL BY HIMSELF. ONCE THE IMPEDANCES WERE CHECKED WITH CONTACT 0 AND IRREGULAR DATA SHOWED. CONTACT 0 WAS NOT BEING USED. THE DEVICE WAS SET AT: C+1-, 2.4V, UPPER LIMIT 1.0V, LOWER LIMIT 0.6V, 170HZ, 210US. THE STIMULATION SETTINGS ON BOTH SIDES WERE NORMAL. IT WAS UNKNOWN IF REMOVAL/RESETTING THE OOR WAS NECESSARY. STIMULATION WAS WORKING NORMALLY. IT WAS UNKNOWN IF THE CAUSE WAS THE SETTINGS OF THE REMOTE CONTROL OR THE INS. THE INDICATION FOR USE INCLUDED PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332665 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1