BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7429956 · Received April 13, 2018

    Report

    Report Number
    3004209178-2018-08005
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    January 31, 2018
    Report Date
    April 13, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169105492
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT USED FOR OFF-LABEL USE. PRODUCT CODE FOR DYSTONIA IS MRU. 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 WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR DYSTONIA, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE CALLER SAID THE PATIENT HAD BEEN HAVING TROUBLE CHARGING. AT FIRST THE PATIENT WAS ABLE TO KEEP THEIR INS CHARGED AT 50% OR BETTER, BUT FOR THE PAST 2.5 MONTHS THEY COULDN'T KEEP THE CHARGE "ABOVE 2 BARS." CALLER WAS NOT SURE IF THEY WERE TALKING ABOUT THE BATTERY CHARGE OR COUPLING BARS, AND THE CALLER DIDN'T HAVE ACCESS TO THE PATIENT OR EQUIPMENT. CALLER TRIED TO CONTACT THE REP BUT JUST GOT A VOICEMAIL. PAIN WAS A REPORTED SYMPTOM. PATIENT WAS IN PAIN FROM THE DYSTONIA BECAUSE THE INS WAS NOT WORKING UP TO PAR. THE CALLER CALLED BACK AND STATED THAT THE PATIENT WAS IN EXCRUCIATING PAIN BECAUSE THE IMPLANT WAS NOT HELPING. CALLER STATED ABOUT A WEEK AFTER THE IMPLANT THEY TURNED THE STIMULATION ON AND GOT THE "BATTERY GOING." CALLER STATED THEY HAD YET TO PROGRAM IT AND REALLY HELP WITH THEIR DYSTONIA PAIN. CALLER STATED THEY HAD BEEN WORKING WITH THE HCP AND WERE TOLD THAT IT COULD TAKE TIME (UP TO A YEAR) TO GET THE PROGRAMMING RIGHT SO THAT IT HELPS. CALLER STATED THE IMPLANT WAS IN THE PATIENT'S CHEST. CALLER DIDN'T KNOW IF THE PATIENT USED HOLSTER OR ADHESIVES. CHARGINS ISSUES BEGAN EVER SINCE THEY HAD THE DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271672 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169105492

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR