BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2041687 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01402
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE IMPEDANCE MEASUREMENT. AT THE TIME NO FRACTURE WAS NOTED AND THE PHYSICIAN CONFIRMED A GOOD LEAD TO DEVICE CONNECTION. POST SURGERY THE RV LEAD IMPEDANCE MEASUREMENT DECREASED, BUT WAS STILL OUT OF RANGE. THE PHYSICIAN OPTED TO RECHECK THE LEAD THE FOLLOWING MORNING. ONE DAY POST IMPLANT, THE RV LEAD IMPEDANCE MEASUREMENT HAD DECREASED AND WAS WITHIN NORMAL LIMITS. ALTHOUGH THE CAUSE OF THE OUT OF RANGE IMPEDANCE MEASUREMENTS WERE UNKNOWN, DRIED BLOOD ON THE IS-1 PIN WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 4088| 4457| 4086| S606