BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 4860780 · Received June 22, 2015

    Report

    Report Number
    2017865-2015-08020
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 22, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCING PRESYNCOPE, PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2015. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402921 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5386 0002304912

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention