BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910077 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15296
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS NOTED ONLY THE DISTAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL INSPECTION REVEALED EVIDENCE OF CALCIFICATION OVER THE DISTAL SHOCKING COIL. DEPENDING ON HOW MUCH CALCIFICATION WAS ON THE TIP BEFORE THE LEAD WAS EXPLANTED, THE IMPEDANCE MEASUREMENT COULD HAVE BEEN AFFECTED. THE LEAD DID PASS ELECTRICAL RESISTANCE TESTING CONFIRMING THE CONDUCTOR WAS INTACT. NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH SHOCK IMPEDANCE LEVELS UP TO 136 OHMS WITH A COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A REVISION PROCEDURE WAS PERFORMED TO EXPLANT AND REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18917 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0164

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R