BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 20536777 · Received October 25, 2024

    Report

    Report Number
    1723170-2024-03310
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733597, LOT#: 130917, G2: FOREIGN COUNTRY - JAPAN, H3/H6: THE SYSTEM WAS SERVICED AND THE LEMO CABLE WAS REPLACED. CODES B01, C02, AND D02 APPLY. THE CABLE WAS RETURNED FOR ANALYSIS. THE LEMO CABLE WAS BENT NEAR THE Y CONNECTION AND THERE WERE SMALL CUTS IN THE CABLE JACKET NEAR THE STRAIN RELIEF. A CONTINUITY TEST REVEALED AN OPEN AT THE #1 PIN OF THE USB CABLE ALONG WITH A SHORT FROM THE #4 PIN TO GROUND. CODES B01, C02, AND D02 APPLY. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE POWER DATA CABLE WAS DISCONNECTED AND FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721874 CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11."