BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN LINK 3 US

    MDR report key: 16292090 · Received February 3, 2023

    Report

    Report Number
    2032227-2023-142376
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    October 13, 2021
    Report Date
    February 3, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION. CUSTOMER REPORTS RECENTLY BEING HOSPITALIZED DUE TO A HEART ATTACK. CUSTOMER WAS WEARING PUMP AND TRANSMITTER AT TIME OF CT SCAN AND MRI SCAN AND IS UNABLE TO CONNECT XMTR TO PUMP. WAS SENT REPLACEMENT PUMP AND XMTR DUE TO UNAVOIDABLE EXPOSURE TO MAGNETISM FROM MEDICAL TESTS. UNIT PASSED VISUAL INSPECTION USING MICROSCOPE. UNIT WAS ABLE TO CHARGE, COMMUNICATE, AND SYNCED PROPERLY DURING RF/BLE ASSOCIATION. UNIT PASSED FUNCTIONAL TEST INCLUDING ACCURACY TEST AT: ISIG LOW VALUE AT 2.48 NA. ISIG HIGH VALUE AT 150.93 NA. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT NO COM PUMP TO XMTR-UNRESOLVED OCCURRED. THERE WAS AN ALLEGATION OF CARDIAC ARREST AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846529 GUARDIAN LINK 3 US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7911NA 1007257

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Hospitalization