BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3210871 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08204
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD SAFETY SWITCH (LSS). THE PATIENT'S SYSTEM WAS EVALUATED. THE DAILY MEASUREMENTS WERE STABLE. THE IN-OFFICE IMPEDANCE VALUES FOR BOTH UNIPOLAR AND BIPOLAR WERE NORMAL BETWEEN 380-420 OHMS. THERE WAS ONE EPISODE OF NOISE LISTED AS A ATRIAL TACHY RESPONSE (ATR) IN THE LOGBOOK. PACING WAS INHIBITED HOWEVER, THE PATIENT HAD AN UNDERLYING RHYTHM. ADDITIONALLY, IT WAS NOTED THAT THERE WERE A FEW OTHER EPISODES OF NOISE WHICH WAS INDICATIVE OF ELECTROMAGNETIC INTERFERENCE (EMI) AS IT APPEARED ON BOTH THE ATRIAL AND VENTRICULAR CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE. THE PATIENT WAS TO BE FURTHER EVALUATED AT A LATER DATE. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WAS LATER EVALUATED AND THE ISSUE HAD PROGRESSED AS THERE WERE MORE STORED EPISODES OF NOISE AND THE NOISE WAS ABLE TO BE REPRODUCED IN THE CLINIC. THE PACING THRESHOLDS HAD ALSO INCREASED FROM 0.8 VOLTS TO 1.3 VOLTS AND THERE WAS A DAILY PACING IMPEDANCE MEASUREMENT IN THE 100'S. THE PATIENT WAS NOT DEPENDENT ON ATRIAL THERAPY THEREFORE, THE PHYSICIAN WILL CONTINUE TO MONITOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310130 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4086| 4087| S603