BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1954080 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24213
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ANALYSIS REVEALED THAT THE INNER AND OUTER INSULATION OF THE LEAD WAS ABRADED THROUGH. THIS FINDING MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. THE ABRASION COULD HAVE BEEN RUBBED BETWEEN THE INNER AND OUTER COILS. THE ABRASION WAS AT 31-32CM FROM THE TERMINAL PIN; POSSIBLY DUE TO LEAD-ON-LEAD CONTACT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAS SUDDENLY EXHIBITED DECREASED IMPEDANCES OF 100 OHMS, LOSS OF CAPTURE WITH NO PACING THRESHOLD, AND NOISE. NO PACING INHIBITION GREATER THAN 2 SECONDS ASYSTOLE WAS OBSERVED AS THE PATIENT HAD AN INTRINSIC RHYTHM. A REVISION PROCEDURE WAS PERFORMED; DURING THE PROCEDURE, THE PATIENT DEVELOPED A HEMOTHORAX WITH PERICARDIAL EFFUSION WHICH REQUIRED CARDIO-PULMONARY RESUSCITATION. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT IS RECOVERING IN THE CRITICAL CARE UNIT. THE EXPLANTED LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening