BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9319586 · Received November 13, 2019

    Report

    Report Number
    3004209178-2019-21748
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 8, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00643169864238
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PMA: MODEL 37612 ACTIVA RC IS NOT APPROVED FOR DYSTONIA (PMA: H020007); THEREFORE, USE OF THE DEVICE FOR THE TREATMENT OF DYSTONIA (AS IN THIS CASE) IS CONSIDERED AN OFF LABEL INDICATION FOR USE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA2305K, IMPLANTED: 2019-10-25 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# VA1SPHV, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# :VA1S2VR, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: VA1SPHV, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: VA1S2VR, IMPLANTED: 2018-08-30 EXPLANTED: 2019-10-25 PRODUCT TYPE: LEAD, PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 30-MAY-2022, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 24-APR-2021, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 24-APR-2021, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 24-APR-2021, UDI#: (B)(4) ; PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 24-APR-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER MULTIPLE RE-PROGRAMMING ATTEMPTS, THE THERAPEUTIC RESULTS WERE NOT SATISFACTORY. THE EXACT CAUSE OF THE THERAPY ISSUE WAS NOT KNOWN. ALL FOUR OF THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2019. ONE OF THE NEWLY IMPLANTED LEADS WAS FOUND TO BE IMPLANTED TOO SUPERIOR TO THE INTERNAL GLOBUS PALLIDUS (GPI), ALTHOUGH THE CAUSE OF THIS POSITIONING ISSUE WAS NOT KNOWN. A SECOND REVISION WAS PERFORMED ON THE SAME DATE TO RESOLVE THIS. ALL FOUR NEW LEADS WERE CONNECTED, IMPEDANCES WERE GOOD AND NO OTHER ISSUES WERE IDENTIFIED. POST-OPERATIVE CT IMAGING SHOWED GOOD POSITION OF ALL LEADS AND THE PATIENT WAS GETTING GOOD RESULTS WITH THE THERAPY. THE EVENT WAS CONSIDERED RESOLVED. REFER TO MANUFACTURER REPORT #3004209178-2019-21745 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113600 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention