BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040701 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00154
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE REVISION PROCEDURE, THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT PRE SURGICAL MEASUREMENTS CONFIRMED OUT OF RANGE PACING IMPEDANCES AS WELL AS A RISE IN PACING THRESHOLDS ON THIS RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION, CONTINUITY TESTING, AND X-RAY EXAMINATION REVEALED NO EVIDENCE OF A CONDUCTOR FRACTURE. FURTHER VISUAL INSPECTION REVEALED EVIDENCE OF CALCIFICATION COVERING OVER A PORTION OF THE DISTAL MESH TIP ELECTRODE. DEPENDING ON HOW MUCH CALCIFICATION WAS ON THE TIP OF THE LEAD BEFORE IT WAS EXPLANTED, THE IMPEDANCES MEASUREMENTS COULD HAVE BEEN AFFECTED. LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP AN INCREASE IN PACING IMPEDANCES WAS NOTED. THE PACING IMPEDANCES WERE OUT OF RANGE. THE RIGHT VENTRICULAR SENSING AND PACING THRESHOLDS WERE NORMAL. A CHEST X-RAY DID NOT REVEAL A LEAD FRACTURE, DUE TO THE OUT OF RANGE PACING IMPEDANCES A RIGHT VENTRICULAR LEAD REVISION HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143953 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1