BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8378562 · Received February 28, 2019

    Report

    Report Number
    3004209178-2019-04233
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 18, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT (B)(6) 2019 IS AN ESTIMATE. 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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THERE HAVE BEEN POWER OUTAGES OVER THE LAST COUPLE DAYS. IT WAS STATED THAT PATIENT WENT TO CHARGE TODAY AND INS DOES NOT CHARGE PAST 50%, LAST TIME PATIENT CHARGED FOR 2 HOURS. THE HCP TRIED TO CHARGE WITH THE PATIENT PRIOR TO THE REPORT AND SAW THAT THE INS WOULD NOT GO ABOVE 50%. THE HCP PUT THE INS RECHARGER (INSR) INTO AL MODE TO TEST IF ANTENNA WAS WORKING PROPERLY. 38-38-38 IN THE AIR 104-130-158 ON METAL AND CONFIRMED NO ISSUES WITH THE ANTENNA, THE TECHNICAL SERVICES SPECIALIST (TSS) WAS ABLE TO CLARIFY THAT PATIENT NEVER RECEIVED A PROMPT STATING THAT INS WAS FULLY CHARGED, RATHER THE INS ICON WOULD FLASH AT 50%. THE HCP NOTED TOWARDS THE END OF THE CALL THAT PATIENT WAS CONSISTENTLY ABLE TO CHARGE IN 23 MINUTES IN THE PAST BUT NOW IT'S NOT CHARGING THE SAME. PER THE PROVIDED RECHARGING STATS , IT WAS CONFIRMED THAT INSR BEHAVIOR IS APPROPRIATE WITH CURRENT INS BATTERY LEVEL. THE DATA SHOWS THAT THE PATIENT HAD NEVER CHARGED INS TO FULL AND WAS NOT GETTING 8/8 COUPLING. IT WAS REVIEWED FOR THE CALLER THAT CHARGING TIMES CAN VARY DEPENDING ON COUPLING AND INS BATTERY LEVEL AND ALSO REVIEWED BEST PRACTICES AND MONITOR. NO SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY WERE UNABLE TO CHARGE THE IMPLANT PAST 50% AFTER CHARGING FOR AN HOUR THAT MORNING. THE CONSUMER WAS EDUCATED ON INCREMENT LEVELS AND COUPLING BOXES. THE CONSUMER WAS GOING TO ATTEMPT TO CHARGE THE IMPLANT FOR A LONGER AMOUNT AND TIME. LATER THAT DAY THE CONSUMER WAS CONTACTED WHO STATED AFTER CHARGING FOR 1.5 HOURS THE IMPLANT WAS IN THE LAST CHARGING QUARTILE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171203 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR