BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9564251 · Received January 8, 2020

    Report

    Report Number
    3007566237-2020-00037
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    November 30, 2019
    Report Date
    October 20, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D2/G5(PMA): UPDATED TO REFLECT ACTIVA RC, WHICH IS APPROVED UNDER PMA P960009 AND PROCODE MHY. 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 · 0

    UPDATED SERIAL # AS IT WAS MISSING THE ENDING "H". CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761 LOT# SERIAL# (B)(6), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL#: UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37651, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: UNKNOWN, UBD: N/A , UDI#: (B)(4). (PMA): THE ACTIVA RC INS IS NOT APPROVED IN THE US FOR DYSTONIA INDICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEEP BRAIN STIMULATION (DBS) THERAPY WAS FOUND TO BE OFF, BUT THE PATIENT INSISTED THE INS WAS BEING RECHARGED. THE INS WAS REPORTED TO BE "WITH NO BATTERY". A VIDEO CALL WAS PERFORMED TO TROUBLESHOOT, BUT NO ISSUE WAS IDENTIFIED. A VISUAL INSPECTION WAS PERFORMED AT THE HOSPITAL, WHICH FOUND DAMAGE TO THE RECHARGER CONNECTION TO THE ELECTRICITY (THE BLACK PLUG). THE RECHARGER BATTERY WAS UNABLE TO CHARGE, AND THUS THE INS COULD NOT BE CHARGED WITH IT. THE RECHARGER WILL BE REPLACED, AND THE PATIENT'S INS WAS RECHARGED TO 75%. THE LAST CHARGING SESSION BEFORE THE RECHARGER SYSTEM FAILURE WAS ON (B)(6) 2019, BUT THE INS WAS CONFIRMED TO NOT BE IN OVER DISCHARGED STATE. THE PATIENT WILL GO TO THE HEALTH CARE PROVIDER (HCP) OFFICE TO RECHARGE UNTIL A NEW RECHARGER IS PROVIDED. THE EVENT RESULTED IN LESS THAN 50% THERAPY RELIEF, MOUTH (RIGHT FACE) DYSTONIA, AND MEDICAL/SURGICAL INTERVENTION (BOTOX APPLICATION) WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THE EVENT WAS CONSIDERED RESOLVED WITH DBS THERAPY NOW ON AND WORKING PROPERLY. THE PATIENT WAS IMPLANTED FOR DYSTONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28294 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention "SEE H10...."