BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLANAR BLUNT PROBE

    MDR report key: 20926324 · Received December 13, 2024

    Report

    Report Number
    1723170-2024-03912
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    December 4, 2023
    Report Date
    December 13, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000223069
    PMA / PMN Number
    K972398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA: 624392. F26: NO PATIENT IMPACT F1908: 30 SECOND DELAY A0709: TRACKING ISSUES A05: BENT PROBE H3, H6: THE RETURNED PROBE WAS ANALYZED. NO FAILURES WERE FOUND. CODES B01, C19, AND D14 ARE APPLICABLE. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THAT DURING A CASE, THE PASSIVE PLANAR PROBE WAS UNABLE TO BE TRACKED. A MEDTRONIC REPRESENTATIVE (REP) ARRIVED ON SITE AND REPORTED THAT THE TOP LEG OF THE PROBE WAS VISIBLY BENT TO THE LEFT SIDE. WHEN THE INSTRUMENT WAS HELD IN FRONT OF THE CAMERA, THE GEOMETRY ERROR OF THE PROBE WAS 0.8 MM. WHEN THE TOP SPHERE WAS COVERED, THE GEOMETRY ERROR DROPPED TO 0.4 MM AND THE INSTRUMENT COULD BE TRACKED. WHEN COVERING ANY OTHER SPHERE, THE GEOMETRY ERROR REMAINED AT 0.8 MM. THERE WAS A 30 SECOND DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414743 PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 960-556 191106 00763000223069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown