BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 16789168 · Received April 21, 2023

    Report

    Report Number
    2182208-2023-01113
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    February 7, 2022
    Report Date
    April 21, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ACUTE TISSUE ISCHEMIA AFTER IMPLANTABLE LOOP RECORDER REPLACEMENT. THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTRO PHYSIOLOGY. 2022 JUN; 64(1):233. PMID: 35129784 DOI: 10.1007/S10840-022-01139-7. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED 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. 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    LITERATURE WAS REVIEWED REGARDING ACUTE TISSUE ISCHEMIA AFTER IMPLANTABLE CARDIAC MONITOR (ICM) REPLACEMENT. THE AUTHORS DESCRIBED A PATIENT WHO WAS IMPLANTED WITH AN ICM. APPROXIMATELY ONE WEEK LATER, THE PATIENT NOTED AN ULCERATIVE LESION OF THE SKIN WHICH INCREASED IN SIZE DURING THE FOLLOWING DAYS. THE PATIENT PRESENTED TO THE CLINIC AND A THICK ESCHAR WAS REMOVED, WHICH REVEALED A NECROTIC AREA IN STRICT PROXIMITY TO THE SUPEROLATERAL ASPECT OF THE DEVICE POCKET. THERE WAS NO EVIDENCE OF LOCAL OR SYSTEMIC INFECTION (NO ERYTHEMA, NO HEAT, NO SWELLING, NO PUS, NO CONTINUITY SOLUTION ALONG THE INCISION, NO FEVER) AT THE SURGICAL WOUND. THE LESION WAS CLEANED WITH MOIST CARE ONCE A WEEK FOR TWO MONTHS AND HEALED. THE STATUS OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791059 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention