BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9735669 STEALTH S8 EM ENT

    MDR report key: 9612355 · Received January 21, 2020

    Report

    Report Number
    1723170-2020-00202
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID :9735787 , SERIAL/LOT #:18190486, UBD: , UDI#: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735881, LOT NUMBER IS UPDATED TO: 190814 H3) PRODUCT ANALYSIS FOR WAS RETURNED IT WAS TESTED AND NOTED THAT WHEN CONNECTING THE RETURNED UPS TO AC THERE WAS A POPPING NOISE AND THE UNIT DID NOT POWER ON. UNABLE TO PROCEED WITH FURTHER TESTING. THE REPORTED ISSUE OF NO POWER WAS CONFIRMED. THE ANALYSIS FOR THE OTHER CONCOMITANT PRODUCT CAME BACK AFTER TESTING, IT WAS NOTED THAT THERE WAS NO FAILURE FOUND. H6) IS CODED FOR BOTH CONCOMITANT PRODUCTS RETURNED FOR ANALYSIS 10,120 ,4307. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. THE REPRESENTATIVE WENT OUT TO SERVICE THE SITE, AND THE SYSTEM WOULD NOT POWER ON. THE REPRESENTATIVE WITNESSED A HARDWARE FAILURE. HE REPLACED THE FUSES AND THE GENERAL FAILURE WAS RESOLVED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735881, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED ON FRIDAY, (B)(6) THAT WHEN THE SITE TURNED AWAY, THE SYSTEM SHUT DOWN AND WOULD NOT POWER BACK ON EVEN AFTER A FULL WEEKEND OF CHARGING. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74128 9735669 STEALTH S8 EM ENT INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1