BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3043253 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02049
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    September 15, 2011
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. 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 AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER IMPLANT, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. IT WAS NOTED THAT THE LEAD HAD BEEN INTENTIONALLY IMPLANTED ON THE RIGHT ATRIAL FLOOR. APPROXIMATELY 15 MONTHS LATER, THE PATIENT WAS SCHEDULED TO HAVE AN ATRIAL FLUTTER ABLATION AND BE UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEVICE. AT THE PROCEDURE, ATRIAL UNDERSENSING OF THE ATRIAL FLUTTER WAS OBSERVED. IMAGINING REVEALED THAT THE RA LEAD REMAINED ON THE ATRIAL FLOOR, BUT MICRODISLODGEMENT COULD NOT BE RULED OUT. BASED ON THE HISTORY OF HIGH THRESHOLDS, AND THE CURRENT UNDERSENSING, IT WAS DECIDED TO REVISE THE RA LEAD AT THE TIME OF THE UPGRADE. THIS LEAD WAS SUCCESSFULLY EXPLANTED AND A NEW RA LEAD IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147185 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4087| S606| 4086