BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 25033898 · Received April 29, 2026

    Report

    Report Number
    3004209178-2026-07429
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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

    IT WAS REPORTED THAT UPON RUNNING IMPEDANCES AT 1.0 MA CONTACT 2C WAS GREATER THAN 5K OHMS AND EVERYTHING ELSE WAS NORMAL. CALLER RAN SOME CURRENT THROUGH 2C TO SEE IF IT WOULD NORMALIZE, BUT THEY DIDN'T SEE ANY SIGNIFICANT CHANGE IN IMPEDANCE. CALLER THEN RAN IMPEDANCES USING AUTOMATIC RAMP-UP AND EVERYTHING CLEARED FINE ON THE LEFT (INCLUDING 2C), BUT THE 2 MIDDLE ONES ON THE RIGHT SIDE WERE HIGH. CALLER RE-RAN AGAIN AT 1.0 MA AND 2C WAS HIGH, BUT EVERYTHING CLEARED ON THE RIGHT SIDE. CALLER ALSO RAN AT 0.4 MA AND EVERYTHING CLEARED EXCEPT FOR 2C. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT REVIEWED HOW RUNNING IMPEDANCE AT DIFFERENT AMPLITUDES HAVE DIFFERENT OUT OF RANGE THRESHOLDS AND HOW THAT CAN AFFECT RESULTS. AGENT REVIEWED MRI CONSIDERATIONS WITH IMPEDANCES PRESENTING IN THIS WAY AND SUGGESTED TO MONITOR THE ISSUE GOING FORWARD GIVEN THAT PATIENT IS SO NEWLY IMPLANTED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16649 PERCEPT Stimulator, electrical, implanted, for parkinsonian tremor MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male