BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3790217 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-06698
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND CAREFULLY EXAMINED. VISUAL ANALYSIS NOTED TRILUMEN INSULATION ABRASION 115-188 MILLIMETERS (MM) FROM THE TERMINAL PIN. THERE WERE SET SCREW MARKS ON THE TERMINAL PINS AND BLOOD OR BODY FLUID IN THE LUMENS. THE LEAD PASSED ELECTRICAL TESTING. DETAILED ANALYSIS REVEALED A SURFACE ABRASION WITH THE INSULATION ABRADED THROUGH TO THE DISTAL AND PROXIMAL HIGH VOLTAGE (HV) LUMENS 160-182 MM FROM THE TERMINAL PIN. WEBBING DAMAGE WAS NOTED BETWEEN ALL THREE LUMENS IN THIS AREA. THE DISTAL HV POLYTETRAFLUOROETHYLENE (PTFE) WAS WORN/ABRADED AS WELL AND THERE WAS MELTED METAL (ARCING DAMAGE) NOTED ON THE DBS CABLE. THE ABRASION WOULD MOST LIKELY HAVE BEEN LOCATED IN THE POCKET AREA. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT APPEARS IT WAS MOST LIKELY CAUSED BY LEAD-ON-CAN CONTACT COUPLED WITH PRESSURE AND MOVEMENT WITHIN THE POCKET AREA.

    Additional Manufacturer Narrative · 1

    THE LEAD IS EXPECTED TO BE RETURNED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE SYSTEM WAS NOT TESTED WITH A PACING SYSTEM ANALYZER (PSA) AS THE LEAD WAS CLEARLY BROKEN. AS THE SURFACE OF THIS DEVICE WAS ALSO SLIGHTLY DISFIGURED, THIS LEAD TO THE PHYSICIAN TO DECIDE TO REPLACE BOTH COMPONENTS ON HAND. THE DEVICE WAS NOT TESTED AFTER REMOVAL AS IT WOULD HAVE REQUIRED THE USE OF A NEW LEAD FOR TESTING. THE PATIENT IS NOT PACEMAKER DEPENDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT LESS THAN 200 OHMS. SUBSEQUENTLY, UPON INSPECTION OF THE LEAD DURING EXTRACTION, IT WAS DISCOVERED THAT THE LEAD CONDUCTOR HAD FRACTURED AND THE INSULATION OF THE PROXIMAL END WAS DAMAGED. THE SYSTEM WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. NO ADDITIONAL 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
    267671 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R T175| F141| 0185