BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2910246 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15132
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    January 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF DEVICE (S502, SN: (B)(4)) AND (S502, SN: (B)(4)) WAS PERFORMED. NO ANALYSIS WAS COMPLETED ON THE RIGHT ATRIAL (RA) LEAD AS THIS LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC; THEREFORE A ROOT CAUSE OF THE LEADS ABNORMALITIES COULD NOT BE CONFIRMED. A VISUAL INSPECTION OF BOTH DEVICE HEADERS AND CASES NOTED NO ANOMALIES. BOTH DEVICES WERE THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. BOTH DEVICES OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. BOTH DEVICES (S502, SN: (B)(4)) (S502, SN: (B)(4)) MET SPECIFICATION AND WERE ARCHIVED AT BOSTON SCIENTIFIC.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE AND LEAD HAVE BEEN RETURNED FOR ANALYSIS. TO DATE THE EXPLANTED DEVICE AND LEAD HAVE NOT BEEN RETURNED TO BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND RIGHT ATRIAL (RA) LEAD WAS HOSPITALIZED DUE TO AN ATRIAL LEAD REVISION FOR UNDERSENSING. AFTER THE LEAD WAS REPOSITIONED THE LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER (PSA) AND ALL MEASUREMENTS WERE NORMAL AND WITHIN RANGE. THE LEAD WAS THEN CONNECTED TO THE DEVICE AND TESTED AGAIN; MEASURMENTS WERE LOW. DURING THE REVISION IT WAS SUSPECTED THAT THERE MAY HAVE BEEN BLOOD IN THE PACEMAKER HEADER AND POSSIBLE UNDERSENSING MAY HAVE OCCURED FOR AN UKNOWN DURATION WITH THE PACEMAKER. THE DECISION WAS MADE TO EXPLANT THE DEVICE AND LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16728 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R