BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY SR

    MDR report key: 1896485 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05257
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WITH AN INTRINSIC RATE OF 30 BPM AND NO PULSE GENERATOR OUTPUT. INTERROGATION FOUND THAT THE DEVICE WAS OPERATING WITH ORIGINAL SETTINGS OF VVI 70 BPM. ALTHOUGH ECG PACING SPIKES WERE OBSERVED, MEASURED DATA POST INTERROGATION SHOWED A THRESHOLD OF 1.25 V, 0.4 MS WITH A SAFETY MARGIN OF 3.0 V. THE FOLLOWING DAY, INTERROGATION REVEALED NO ANOMALIES. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention