BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2162554 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07233
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 14, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS CURRENTLY BEING HOSPITALIZED UNTIL ANOTHER IMPLANTATION PROCEDURE CAN BE PERFORMED. THE RV LEAD WILL BE RETURNED FOR LABORATORY ANALYSIS. ONCE ANALYSIS IS 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 FOUND THAT THERE WERE MARKS ON THE TERMINAL PIN AND ELECTRODE RING BUT THEY DID NOT RESEMBLE A SETSCREW MARK. THE HELIX WAS RETRACTED AND THERE WAS BLOOD INFILTRATION IN THE HELIX HOUSING RESULTING IN THE HELIX MECHANISM NOT EXTENDING THE HELIX DURING TESTING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF LOSS OF CAPTURE. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES AND THIS LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANTATION OF THIS RIGHT VENTRICULAR (RV) LEAD, DIFFICULTIES WERE ENCOUNTERED WHEN PLACING THE LEAD IN THE VENTRICLE. AFTER SEVERAL ATTEMPTS, THE LEAD WAS SUCCESSFULLY PLACED AND ACCEPTABLE MEASUREMENTS WERE OBTAINED. HOWEVER, THEN THE LEAD WAS CONNECTED TO THE DEVICE, LOSS OF CAPTURE WAS NOTED RESULTING IN PAUSES BETWEEN 5 TO 10 SECONDS. TESTING WAS PERFORMED AGAIN DURING THE PROCEDURE AND LOSS OF CAPTURE WAS STILL OBSERVED. THE LEAD WAS REPOSITIONED AND MEASUREMENTS WERE AGAIN TAKEN, BUT LOSS OF CAPTURE AGAIN OCCURRED WITH THIS RV LEAD. THE PATIENT THEN SUDDENLY TOUCHED THE POCKET REGION AND THE LEAD WAS EXPLANTED AND THE PROCEDURE WAS ENDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O