BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8797952 · Received July 17, 2019

    Report

    Report Number
    3004209178-2019-13684
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 2, 2019
    Report Date
    November 10, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    UDI-DI
    00613994934611
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2: PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR DYSTONIA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN DEVICE DESCRIBED IN SECTION D IS NOT APPROVED UNDER PMA/510K # H020007 FOR THE DESCRIBED INDICATION: DYSTONIA (PRODUCT CODE: MRU). 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 IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THEY NOTICED TODAY THE INS WAS OFF, WHICH HAPPENED ON ITS OWN, AND THE PATIENT'S BODY WAS GOING CRAZY. THEY HAD BEEN CHARGING FOR A HALF HOUR WITH POOR COUPLING, AND IT WAS STILL SHOWING STIMULATION WAS OFF. THE PATIENT CONFIRMED THE INS BATTERY WAS BLINKING AT THE FIRST QUARTILE. IT WAS REVIEWED STIMULATION WOULD REMAIN OFF UNTIL THE PATIENT'S BATTERY WAS CHARGED TO 25%. THEY WERE NOT SURE WHY THE BATTERY DEPLETED THIS TIME BECAUSE THEY ARE ON THE SAME CHARGING SCHEDULE EVERY WEEK. THERE WERE NO CHANGES TO PROGRAMMING OR ANY FALLS OR TRAUMA REPORTED. IT WAS REVIEWED THE NUMBER OF EFFICIENCY BARS WILL AFFECT RECHARGE TIME. THEY WERE REDIRECTED TO THE HEALTHCARE PROVIDER (HCP) IF RECHARGING FREQUENCY BECOMES MORE FREQUENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THERE REALLY WASN'T AN ISSUE. THE PROBLEM WAS THAT THE DEEP BRAIN STIMULATION (DBS) SHUT OFF BECAUSE IT UNEXPECTEDLY WENT SO LOW ON BATTERY. THEY WERE NOT ABLE TO TURN IT BACK ON UNTIL THE BATTERY WAS AT LEAST 1/4 FULL. ONCE THE BATTERY CHARGED FOR AN HOUR, THEY WERE ABLE TO TURN THE INS BACK ON, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593897 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR