BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3213102 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09705
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED TO THE EMERGENCY ROOM FOLLOWING A SYNCOPAL EPISODE. THE PATIENT PRESENTED WITH INTERMITTENT LONG PAUSES AND AN ESCAPE RHYTHM IN THE 30 BEATS PER MINUTE (BPM) RANGE. THE DEVICE WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER. IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313424 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 1226| 4261| MISMATCH| 1296