BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 19816459 · Received July 24, 2024

    Report

    Report Number
    3004209178-2024-15335
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 7, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    PJS
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 REFERENCES: PRODUCT ID A610 PRODUCT TYPE SOFTWARE PRODUCT ID B35300 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. 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.

    Additional Manufacturer Narrative · 0

    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

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED THE PATIENT WAS EXPERIENCING SYMPTOMS FOLLOWING INS REPLACEMENT YESTERDAY (THEY WENT FROM PERCEPT PC TO PERCEPT RC). THE REP USED THE REPLACEMENT WORKFLOW PROCESS. IMPEDANCES WERE TAKEN WITH OLD INS AND WERE AROUND THE 700-830 OHMS FOR BOTH SIDES. WITH NEW INS (PERCEPT RC), IMPEDANCES CAME IN HIGH FOR THE LEFT LEAD/EXT. THE HCP REMOVED THE LEADS, WIPED DOWN AND REINSERTED AND RE-RAN IMPEDANCES AGAIN WITH NO CHANGE TO THE IMPEDANCE. HCP SWAPPED PORTS AND SAW IMPEDANCES BACK TO NORMAL RANGE AND LEFT LEADS IN THAT LOCATION. HCP LEFT LEADS IN THIS LOCATION SO REP REPROGRAMMED INS AGAIN TO ENSURE SETTINGS MATCH FOR THE CORRECT SIDE. REP HAD HCP CONFIRM SETTINGS WERE PROPERLY TRANSFERRED TO THE CORRELATE WITH THE CORRECT SIDE. THE PATIENT¿S RIGHT SIDE IS SHAKING AND THE LEFT FACE AND LEFT ARM ARE NUMB. FURTHER CLARIFICATION STATED THE PATIENT HAD "VIOLENT TREMORS: WHEN TESTING IMPEDANCES BUT THOSE TREMORS GO AWAY FOLLOWING THE COMPLETION OF THE IMPEDANCE TEST.¿ IMPEDANCE VALUE DID NOT SAVE IN THE SESSION REPORT DURING THE INTRA-OP TEST. REP HAD PT GO INTO MRI MODE TO CHECK IF DEVICE IS WORKING PROPERLY WHICH IS ALLOWED PT TO TURN OFF THERAPY. PT DOESN'T HAVE ACCESS TO ADJUST THERAPY SETTINGS SO UNABLE TO CONFIRM IF POSSIBLE IMPEDANCE ISSUE. REVIEWED NEED TO MEET WITH PATIENT TO CHECK IMPEDANCES AND PROGRAMMING AGAIN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED. THE SHAKING AND NUMBNESS RESOLVED AS SETTINGS WERE PROGRAMMED INCORRECTLY FROM SURGERY, BUT THE DEVICE WAS PROGRAMMED CORRECTLY ON (B)(6) 2024. THE PATIENT WAS BACK TO BASELINE WITH TREMOR CONTROL ON THE RIGHT SIDE WITH NO SIDE EFFECTS ON THE LEFT ARM OR FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343239 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male