BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1051031 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01339
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    Z2977
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO INFORMATION CAME WITH THE PULSE GENERATOR REGARDING THE EXPLANTING PROCEDURE. FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE DUE TO MULTIPLE FLIPPED BITS. THE BATTERY WAS AT END-OF-LIFE (EOL). AFTER REPLACING THE BATTERY AND DOWN- LOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED.

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ACCORDING TO THE SURGEON, THE PATIENT HAD A HISTORY OF DIABETES WITHOUT RETINOPATHY AND GLAUCOMA (PRE-EXISTING). THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONAIRE. THERE ARE THIRTY NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS THIRTY SEVEN OF THIRTY NINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention