BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 5858596 · Received August 9, 2016

    Report

    Report Number
    2182208-2016-01829
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    January 1, 2016
    Report Date
    June 28, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    1-CARD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS OF THE EVENT PROMPTED A CHANGE IN THE CONCLUSION CODE.

    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/72 YEARS OF AGE. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ORAL ANTICOAGULATION AFTER SUCCESSFUL ATRIAL FIBRILLATION ABLATION OPERATIONS: IS IT NECESSARY? ANNALS OF THORACIC SURGERY. 2016;101(4):1471-1476. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 COMPLICATIONS SUCH AS WOUND INFECTIONS, "NEUROLOGICAL EVENTS [STROKE OR TRANSIENT ISCHEMIC ATTACK], " BLEEDING COMPLICATIONS," AND "OTHER DEVICE-RELATED COMPLICATIONS." THERE WERE REPORTS OF PATIENTS HAVING THEIR ICM REMOVED DUE TO DISCOMFORT." THE STATUS OF THE ICMS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511615 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R