BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 25007217 · Received April 27, 2026

    Report

    Report Number
    3004209178-2026-07264
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MBX
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PRODUCT ID # B35300 S/N: (B)(6) THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. ANALYSIS IDENTIFIED THAT FOREIGN MATERIAL WAS PRESENT IN THE IMPLANTABLE NEUROSTIMULATOR (INS) KIT PACKAGING. SAMPLE APPEARS TO BE A MIXTURE. SAMPLE APPEARS TO BE SOME SORT OF POLYAMIDE. POLYAMIDES HAVE MAJOR PEAKS AT 1539 CM-1 (±16), 1639 CM-1 (±16), AND 3298 CM-1 (±16). POLYAMIDE PEAKS APPEAR TO BE PRESENT IN EACH OF THE PARTICULATE MATTER SPECTRA. POLYAMIDES ARE A BROAD CATEGORY OF POLYMERS THAT INCLUDE PROTEINS AND PEPTIDES. SOME EXAMPLES OF POLYAMIDES ARE COLLAGEN, SILK, WOOL, AND NYLONS. THESE PEAKS APPEAR TO BE PRESENT WITHIN THE SPECTRUM. THERE ALSO APPEARS TO BE SOME CALCIUM PHOSPHATE PRESENT. ADDITIONALLY, THERE APPEARS TO BE SOME SORT OF OIL PRESENT, POSSIBLY A LUBRICANT. 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 CIRCULATOR OPENED BATTERY OUTER PEEL LID AND DISCOVERED UNIDENTIFIED BLACK DEBRIS INSIDE RESTING ON LID OF INNER STERILE PACKAGE. SCRUB TECH TOUCHED PACKAGE BEFORE SEEING AND HAD TO CHANGE GLOVES. PACKAGE WAS TAPED SHUT AND REPLACEMENT BACKUP WAS OPENED AND USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356537 PERCEPT STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED MBX MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female