BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781027 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13360
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 RETURNED SEVERED AT 188 MILLIMETERS (MM) FROM THE TERMINAL PIN. TWO SEGMENTS WERE RETURNED; A TERMINAL END SEGMENT AND A TIP SEGMENT. THE TIP SEGMENT MEASURED 375 MM, WITH THE RATE SENSE (RS)- CONDUCTOR COIL EXTENDING OUT THE SEVERED END OF THE TIP SEGMENT BY 16 MM. THE DISTAL AND PROXIMAL HIGH VOLTAGE CABLES WERE TIED IN KNOTS ALONG WITH A SUTURE, AND ALL FILARS APPEARED TO BE CUT. ALSO, A MID-BODY SEGMENT OF THE LEAD APPEARED TO BE MISSING. THE PROXIMAL SHOCKING COILS WERE STRETCHED AND DEFORMED AT THE PROXIMAL END. THERE WERE CUTS IN THE POLYURETHANE INSULATION AT THE SUTURE SLEEVE TIE-DOWN SITE, AS WELL AS IN THE SUTURE SLEEVE. AN EXTRACTING STYLET WAS RETURNED IN THE TIP SEGMENT OF THE LEAD. A SUTURE WAS TIED DIRECTLY TO THE LEAD INSULATION OF THE TIP SEGMENT FOR EXTRACTING PURPOSES. BODILY TISSUE WAS NOTED WITH SOME CALCIFICATION NOTED ON THE LEAD BODY OF THE TIP SEGMENT AND ON THE PROXIMAL SPRING ELECTRODE. BODILY TISSUE WAS ALSO NOTED ON THE DISTAL SPRING AND WAS ENTWINED IN THE HELIX. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE OF THE RETURNED LEAD SEGMENTS. MEASUREMENTS THROUGHOUT THE TESTING WERE WITHIN NORMAL LIMITS. AN X-RAY WAS PERFORMED AND NO ANOMALIES WERE NOTED. NO FURTHER LEAD TESTING WAS PERFORMED. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF THE RETURNED LEAD SEGMENTS. A MID-SEGMENT PORTION OF THE LEAD WAS NOT RECEIVED FOR ANALYSIS, AND ALL DAMAGE NOTED ON THE LEAD APPEARED TO BE A RESULT OF THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED INTERMITTENT NOISE ON THE RV CHANNEL. IT WAS NOTED THAT THE PATIENT WAS NOT PACEMAKER DEPENDANT, AND WAS NOTED TO HAVE HAD MULTIPLE VENTRICULAR FIBRILLATION (VF) EPISODES AND THREE SHOCKS. ALL EPISODES WERE REPORTED TO HAVE BEEN OVERWRITTEN. THE RV SENSITIVITY WAS REPROGRAMMED AT THAT TIME. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD LATER EXHIBITED A HIGH RV IMPEDANCE MEASUREMENT OF 1,370 OHMS, NOISE ON THE RV CHANNEL WHICH WAS OVERSENSED, CAUSING INAPPROPRIATE SHOCKS AND PACING INHIBITION. A REVISION PROCEDURE WAS PERFORMED AND A LEAD FRACTURE WAS NOTED. THE LEAD WAS THEREFORE EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 1860| 0158