BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 16484461 · Received March 6, 2023

    Report

    Report Number
    2182207-2023-00391
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    December 22, 2022
    Report Date
    June 6, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    00763000519216
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B35200, SERIAL# (B)(4), IMPLANTED: (B)(6) 2021, EXPLANTED: (B)(6) 2023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. REFER TO MANUFACTURER REPORT #3004209178-2023-02490 FOR OTHER IMPLANTED SYSTEM. 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

    H6: FDD/ANNEX A CODE CHANGED TO REFLECT HIGH IMPEDANCES INSTEAD OF GENERAL IMPEDANCES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTICED AFTER BATTERY REPLACEMENT AND HEALTHCARE PROVIDER (HCP) CHECKED IT OUT TO REVISE AS NEEDED. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED. THE CLINICIAN TABLET IMPEDANCE TESTING SHOWED HIGH IMPEDANCES L STN 3,2,0 CONTACTS RT STN 4 CONTACT CONTACT HIGH. HCP WANTED TO SEE IF IMPEDANCES MIGHT RESOLVE WITH NEW BATTERY SO THE BATTERY WAS REPLACED WITH A NEW PERCEPT AND IMPEDANCES IMPROVED FROM HIGH TO MEDIUM LESS THAN 5K ON LEFT SIDE ART SIDE 4 CONTACT CLEARED. THE NEW BATTERY HELPED BUT STILL OUT OF RANGE. HCP IS HOPING TO SEE BETTER NUMBERS AFTER REPLACEMENT RECOVERY AND THEN TAKE NEXT STEPS IF NEEDED. RIGHT NOW THE THERAPY CONTACTS ARE GREEN WITH IN RANGE AND BEING USED FOR THERAPY. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE BATTERY WAS REPLACED. IMPEDANCES WERE TAKEN DURING THE CASE AND THERE WERE STILL SOME OUT-OF-RANGE CONTACTS. THE IMPEDANCE NUMBERS WERE LOWER, ABOUT HALF, BUT THEY WERE STILL IN THE OUT-OF-RANGE LEVELS. THE DECISION WAS TO KEEP THE DEVICE TO SEE IF THEY CLEARED THEMSELVES IN THE NEXT SIX MONTHS (THE NUMBERS STILL WOULDN¿T ALLOW FOR AN MRI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550165 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35200 00763000519216

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention