BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2910610 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15353
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 22, 2012
    Report Date
    January 15, 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

    ONCE THE RV LEAD IS RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THAT THE CONDUCTOR COILS WERE DEFORMED APPROXIMATELY 199 MM FROM THE LEAD'S TERMINAL PIN. THIS DAMAGE WAS MOST LIKELY THE RESULT OF THE SUTURE SLEEVE TIE DOWN. THERE WAS ALSO TISSUE ENTWINED ON THE HELIX AND BLOOD INFILTRATION IN THE HELIX MECHANISM, WHICH RESULTED IN THE HELIX NOT ABLE TO BE EXTENDED OR RETRACTED DURING TESTING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF LOSS OF CAPTURE AND A POSSIBLE MICRODISLODGEMENT OF THIS RV LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD EXPERIENCED A LOSS OF CONSCIOUSNESS ON TWO DIFFERENT OCCASIONS. A PATIENT FOLLOW UP WAS PERFORMED AND IT WAS NOTED THAT THERE WAS INTERMITTENT LOSS OF CAPTURE ON THIS RV LEAD. A REVIEW OF THE CHEST X-RAY FOUND THAT THE LEAD LOOKED WELL POSITIONED; HOWEVER, THE PHYSICIAN DOES BELIEVE THAT THE LEAD MAY HAVE MICRO-DISLODGED AND THE CONTACT WITH THE HEART TISSUE WAS NO LONGER ADEQUATE. A LEAD REVISION WAS PERFORMED AND THIS LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT, THE PHYSICIAN ALSO TESTED THE RV LEAD'S HELIX TO SEE IT WAS FUNCTIONING AND FOUND THAT IT WAS NO LONGER OPERATING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WILL BE RETURNED FOR IMMEDIATE LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16886 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R