BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 1850273 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-19122
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ADVERSE EVENTS REPORTED. THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE, WHICH WAS RECENTLY IMPLANTED, WAS EXHIBITING ELEVATED RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS DURING THE PRE-DISCHARGE SYSTEM CHECK. THE RV PACING IMPEDANCE MEASUREMENTS HAD INCREASED BUT WERE STILL WITHIN NORMAL LIMITS. AT THAT TIME, THE PHYSICIAN PLANNED TO MONITOR THE SYSTEM AND NO INVASIVE INTERVENTION WAS PLANNED. SUBSEQUENTLY, BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSICIOLOGY (EP) LABORATORY. THE POCKET WAS OPENED AND INSPECTION FOUND THAT ONE OF THE RV PACE/SENSE SET SCREWS WAS LOOSE. THE SET SCREW WAS PROPERLY TIGHTENED AND NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R E030| 4470| 0175