BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3052556 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04269
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS SEVERED AT 45 MM FROM THE TERMINAL PIN AND ONLY THE PROXIMAL SEGMENT WAS RETURNED. VISUAL INSPECTION FOUND BLOOD AND BODY FLUID IN THE TERMINAL AREA, ESPECIALLY THE TERMINAL INSULATION AND RING. FURTHER INSPECTION NOTED DEFORMED CONDUCTOR COILS ALONG WITH PUNCTURE HOLES IN THE INSULATION AT 30 MM FROM THE TERMINAL PIN, WHICH WAS DETERMINED TO BE MOST LIKELY FROM SOME TYPE OF GRABBING TOOL. ANALYSIS WAS NOT ABLE TO CONFIRM THE LEADS STUCK IN THE HEADER OF THE DEVICE AS IT WAS DETERMINED THAT THEY WERE ABLE TO BE REMOVED IN THE LAB WITHOUT INCIDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A CHANGE OUT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) FROM THE HEADER OF THE DEVICE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN HAD TO CUT AND SURGICALLY ABANDONED THE LEADS. NEW RA AND RV LEADS WERE SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156457 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR T180| 4087| 0185| T165