BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 6164138 · Received December 9, 2016

    Report

    Report Number
    2182208-2016-02872
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    January 1, 2015
    Report Date
    September 9, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS IS MALE/(B)(6) OF AGE. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿SUBMUSCULAR IMPLANTATION OF INSERTABLE CARDIAC MONITORS IMPROVES THE RELIABILITY OF DETECTION OF ATRIAL FIBRILLATION.¿ JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY 2015 42:2 (143-149).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIAC MONITORS (ICMS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENTS WITH POCKET HEMATOMAS DUE TO THE LOCATION OF THE ICM IMPLANT; THESE LED TO AN ADDITIONAL DAY OF HOSPITALIZATION. THERE WERE ALSO REPORTS OF ARTIFACTS/NOISE SEEN ON THE ELECTROCARDIOGRAMS; AS WELL AS ¿OVERSENSING OF THE ELECTRODES.¿ THE AUTHOR INDICATED THAT THERE WAS A REDUCTION IN NOISE WHEN THE ICM WAS PLACED IN THE ¿SUB-PECTORAL¿ AREA; HOWEVER, THIS APPROACH WAS NOT RECOMMENDED BY THE MANUFACTURER. THE STATUS OF THE ICMS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811985 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R