BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8208731 · Received January 2, 2019

    Report

    Report Number
    3004209178-2019-00047
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 26, 2018
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864214
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40 LOT# VA0JDSS PRODUCT TYPE LEAD. PRODUCT ID 3387S-40 LOT# V A0LZZK PRODUCT TYPE LEAD. PRODUCT ID 37603 SERIAL# (B)(4) IMPLANTED: (B)(6) 2015 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE REP STATED THE LEAD WAS NOT DISLODGED. THE PATIENT UNDERWENT AN IMPEDANCE CHECK, X-RAY, MRI, AND CT WHICH WERE ALL NORMAL. IT WAS UNKNOWN IF THE DEVICE WAS RELATED TO THE FALL. THE REP STATED NO DEVICE ISSUE WAS FOUND AND THE PATIENT HAD BEEN IN THE PROCESS OF ADJUSTING MEDICATION. THE REP STATED THE PATIENT MIGHT NEED TO TURN UP THE PROGRAMMING VOLUME OR ADJUST MEDICATIONS. THE REP DID NOT KNOW THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT#: VA0JDSS, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: VA0LZZK, PRODUCT TYPE: LEAD. PRODUCT ID: 37603, 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: 11-MAR-2017, UDI#: (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 12-JUN-2017, UDI#: (B)(4). 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 A NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE CALLER NOTED THAT THE PATIENT HAD A FALL AND THE PATIENT WAS CONCERNED ABOUT THE INTEGRITY OF THE LEAD. THEY WERE CONCERNED THE LEAD MAY HAVE ¿DISLODGED¿ THOUGH THERE WAS NO EVIDENCE OF THAT AT THE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00643169864214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR