BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3053590 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05141
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT OF THIS ATRIAL LEAD, INTERROGATION REVEALED NUMEROUS ATRIAL TACHY RESPONSE (ATR). ATRIAL LEAD NOISE WAS REPRODUCED BY LEFT ARM MOVEMENTS. THE RIGHT VENTRICULAR CHANNEL WAS UNAFFECTED. AN ATRIAL LEAD FRACTURE WAS SUSPECTED. IMPEDANCE MEASUREMENTS WERE NORMAL. AN XRAY AND FURTHER DECISION REGARDING REVISION WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CHRONIC ATRIAL LEAD HAD BEEN RECONNECTED TO A REPLACEMENT DEVICE APPROXIMATELY THREE MONTHS EARLIER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE DATA WAS PROVIDED TO TECHNICAL SERVICES FOR THEIR REVIEW. THE NOISE APPEARED CONSISTENT WITH A MYOPOTENTIAL PATTERN REPRODUCIBLE UPON ARM MOTIONS. THE X-RAYS DID NOT PROVIDE A CLEAR INDICATION OF LEAD UNDER INSERTION INTO THE DEVICE HEADER. IT WAS DETERMINED THE OBSERVATIONS MAY BE MORE CONSISTENT WITH A LEAD INSULATION OR ABRASION ISSUE. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155855 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1