BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211363 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07898
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 23, 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 THE LEAD WAS PERFORMED. VISUAL ANALYSIS FOUND THAT THE LEAD TIP WAS BENT BETWEEN THE HELIX HOUSING AND ANODE RIGHT AT AN EIGHT DEGREE ANGLE. THERE WAS BLOOD INFILTRATION PAST THE HELIX MECHANISM UP THROUGH THE LEAD LUMEN AND THE HELIX WAS UNABLE TO BE RETRACTED/EXTENDED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION THAT THIS LEAD DISLODGED. DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD HAVE CAUSED THE LEAD TO DISLODGE.

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE LEAD AND COMPLETION OF LABORATORY ANALYSIS, A FINAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ---

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAD DISLODGED DAYS AFTER THE IMPLANT PROCEDURE AND THE PACING IMPEDANCES HAD DECREASED. A REPOSITIONING PROCEDURE TOOK PLACE. WHILE ATTEMPTING TO OBTAIN GOOD MEASUREMENTS, THE HELIX OF THE LEAD WAS NOT FUNCTIONING APPROPRIATELY; THUS, A NEW LEAD WAS IMPLANTED WITH NO FURTHER COMPLICATIONS. THIS RIGHT VENTRICULAR LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309501 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R