BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3212463 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09356
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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 PATIENT'S DEVICE RECORDED RIGHT ATRIAL (RA) LEAD PACE IMPEDANCES OUTSIDE OF NORMAL LIMITS AND CAUSED THE DEVICE TO RECONFIGURE TO UNIPOLAR RA PACING. UPON REVIEW, THE HEALTH CARE PROFESSIONAL (HCP) NOTED THERE WERE NO OUT OF RANGE MEASUREMENTS STORED TO THE DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED MEASURING PACE IMPEDANCES WHILE MANIPULATING THE DEVICE POCKET AND PERFORMING ISOMETRICS TO WHICH THE HCP REPORTED THERE WERE NO OUT OF RANGE IMPEDANCES OR NOISE NOTED. THE LEAD SAFETY SWITCH WAS RESET AND TS ADVISED CONTINUING TO MONITOR THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312730 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4086| 4456| 1290