BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911972 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16537
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 4, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED TRILUMEN INSULATION ABRASION EXPOSING THE RATE SENSE NEGATIVE COIL APPROXIMATELY 49-51CM FROM THE TERMINAL PIN. UNDER X-RAY, THE ABRASION DAMAGE APPEARED TO BE FROM LEAD ON VALVE CONTACT. THE HELIX MECHANISM RETRACTION DIFFICULTY WAS LIKELY DUE TO BLOOD INFILTRATION INTO THE MECHANISM BECAUSE OF THE BREACH IN INSULATION. THE LEAD REMAINED ELECTRICALLY CONTINUOUS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS (LESS THAN 200 OHMS). DURING LEAD EVALUATION, SENSING AND THRESHOLD MEASUREMENTS WERE NOTED TO BE STABLE AND WITHIN NORMAL LIMITS. THE DECISION WAS MADE LEAVE THE LEAD IN SERVICE AND MONITOR. TWO MONTHS LATER, IT WAS REPORTED THAT THIS TRANSVENOUS PACING SYSTEM WOULD BE REPLACED WITH AN S-ICD SYSTEM (BECAUSE OF THE LOW IMPEDANCE MEASUREMENTS). DURING THE REVISION PROCEDURE, THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND STILL YIELDED LOW PACING IMPEDANCE MEASUREMENTS. THE LEAD WAS THEN EXTRACTED. DURING THE EXTRACTION, DIFFICULTY WAS ENCOUNTERED REMOVING THE LEAD TIP. THE EZ4 CONNECTOR TOOL WAS USED HOWEVER THE HELIX WOULD NOT RETRACT WITH 20 TURNS. THE PHYSICIAN THEN TORQUED THE ENTIRE LEAD WHICH FREED THE LEAD TIP ENOUGH TO THEN USE THE EZ4 CONNECTOR TO RELEASE THE HELIX AND REMOVE THE LEAD. UPON THE LEAD BEING REMOVED, IT WAS NOTED A SIGNIFICANT ABRASION JUST PROXIMAL TO THE COIL (SINGLE COIL LEAD) WAS SEEN. THE PATIENT DOES HAVE A MECHANICAL MITRAL VALVE HOWEVER HAS HAD NO PROCEDURES ON HER TRICUSPID VALVE. X-RAY SHOWED THAT THIS PORTION OF THE LEAD WAS LIKELY LAYING ACROSS THE TRICUSPID VALVE. THE ABRASION APPEARS LIKE IT COULD HAVE BEEN A CUT WITH A SCALPEL BUT NO KNOWN ISSUES WERE REPORTED AT THE IMPLANT AND IMPEDANCE MEASUREMENTS WERE REPORTED TO BE WITHIN NORMAL LIMITS DURING IMPLANT TESTING (HOWEVER THE LEAD WAS IMPLANTED WITH A COMPETITOR DEVICE AND NO BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS PRESENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16670 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R MISMATCH| 0292