BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052550 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04267
    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
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF 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 40 MM FROM THE TERMINAL PIN AND ONLY THE PROXIMAL SEGMENT WAS RETURNED. VISUAL INSPECTION REVALED VERY SLIGHT BLOOD AND BODY FLUID IN THE TERMINAL AREA. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION OF THE LEADS BEING STUCK IN THE HEADER.

    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.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154986 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

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