BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7363726 · Received March 22, 2018

    Report

    Report Number
    3004209178-2018-05593
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. THE CALLER REPORTED THAT THE PATIENT HAD BEEN HAVING A LOT OF ISSUES WITH THEIR DYSTONIA THE LAST THREE WEEKS. THE CALLER REPORTED THAT THE PATIENT HAS NOT HAD ANY FALLS OR TRAUMA. THE CALLER REPORTED THAT THE PATIENT "SHUFFLED AROUND AND KIND OF BUMPED INTO THE TV THE OTHER DAY, BUT THAT WAS BECAUSE OF THE VERSED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) WANTED THEM TO SNIFF 3-4 TIMES A DAY." THE CALLER REPORTED THAT WHEN THE PATIENT FIRST GOT THE INS, THEY COULD GO A DAY AND A HALF OR TWO DAYS BEFORE CHARGING, BUT NOW THEY HAD TO CHARGE TWICE A DAY. THE CALLER REPORTED THAT THIS STARTED AT THE END OF LAST WEEK AND THAT THE PATIENT DID NOT HAVE THE ABILITY TO CHARGE THEIR SETTINGS. THE CALLER REPORTED THAT LAST WEEK, THE PATIENT WAS REPROGRAMMED BY THE HCP. THE REP CALLED BACK AT A LATER DATE CLAIMING THE PATIENT WAS CHARGING 1-2 TIMES PER DAY. THEY ALSO CLAIMED THE BATTERY WOULD DEPLETE FROM 100% TO 25% OVERNIGHT. THE FOLLOWING WAS INFORMATION FROM THE 8840: 3/6 DURATION 0 HOURS PERCENT CHARGED AT END OF SESSION 50%. THE 3/5 DURATION 0 HOURS PERCENT CHARGED AT END OF SESSION 50%. THE 3/5 DURATION 0.4 HOURS PERCENT CHARGED AT END OF SESSION 50%. IT WAS REVIEWED THE PATIENT WAS NOT CHARGING FOR LONG DURATIONS AND WOULD BE BEST TO GET A COUPLE OF GOOD CHARGING SESSIONS. THE FOLLOWING WERE IMPEDANCES RUN AT 0.7V. (C0 - 1908, C1 - 749, C3 - 2048 OHMS.) (01 - 2003, 02 - 2184, 03 - 3789). (12 - 998, 13 - 2442). (23 - 2020). R: C8 1430, 8 10 - 2501. THE CALLER RERAN THE IMPEDANCES WITH THE PATIENT HAVING THEIR ARMS ABOVE THEIR HEAD AND PROVIDED THE FOLLOWING VALUES: (L C0 - 1918, C1 - 795, C2 - 595, C3 - 2066). (01 - 2014, 02 - 2191, 03 - 3825). (12 - 1004, 13 - 2459). (23 - 2031). PATIENT SERVICES REVIEWED THAT THE IMPEDANCES WERE NOT CONSISTENT WHICH COULD BE AN INDICATION OF A POTENTIAL INTEGRITY ISSUE. THE FOLLOWING PARAMETERS WERE PROVIDED FOR THE PATIENT'S ACTIVE GROUP AND THE CALLER STATED THAT THE PATIENT DID NOT CHANGE THE PROGRAMMING. (L: AMP: 3.5V 60US 130HZ C+ 2- THERAPY IMP: 587 OHMS). (R: AMP: 3V 90 US 130HZ C+ 9- THERAPY IMP: 708 OHMS. A BATTERY CALCULATION STATED THE TIME FROM 100% TO 0% WAS 2.72 WEEKS. PATIENT WAS ASKED ABOUT NEW RECHARGING ANTENNA AND PATIENT DIDN'T NOTICE A DIFFERENCE IN RECHARGING WITH NEW ANTENNA. THE CALLER STATED THAT THE PATIENT MET WITH A REP IN DALLAS IN (B)(6). THE LATEST CALLER (REP) WAS NOTIFIED A COUPLE DAYS BEFORE THE CALL AND IT WAS THE FIRST TIME MEETING THE PATIENT. INSR RECHARGE STATISTICS SHOWED AN AVERAGE COUPLING OF 0. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTING THAT THEY PATIENT WAS SEEN ON (B)(6)2018 IN THE CLINIC, AND THE FAMILY WAS NOT RECHARGING THE PATIENT'S INS AT LONG ENOUGH INTERVALS (POOR CONTACT TIME.) THE HCP REPORTED THAT THEY WOULD FOLLOW-UP WITH NEUROLOGY REGARDING NEXT STEPS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207127 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR