BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY XL DR

    MDR report key: 2014053 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01747
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH RATES OF 30 TO 50 BEATS PER MINUTE. THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5376 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention