BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3053227 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04858
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    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 A ROUTINE PRE-OPERATION EXAM FOR PULSE GENERATOR (PG) CHANGE OUT, THIS RIGHT ATRIAL (RA) LEAD DISPLAYED PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. NOISE WAS ALSO NOTED. DURING THE PG CHANGE OUT PROCEDURE, AN ATTEMPT TO GAIN ACCESS TO IMPLANT A NEW RA LEAD WAS MADE. ACCESS WAS UNABLE TO BE ACHIEVED. THE LEAD WAS THEN HOOKED UP TO THE NEW PG. ATRIAL CAPTURE WAS ABLE TO BE OBTAINED BUT NOISE WAS STILL PRESENT. THE PATIENT IS NOT DEPENDANT ON THE ATRIAL LEAD SO THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155402 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4087| 4088| 4137| 1298| K063