BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053087 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04540
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE CHANGE OUT, DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AT WHICH TIME A FAULT CODE WAS OBSERVED. TWO SEPARATE DEVICES WERE ATTEMPTED. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FAULTY. FLUORO WAS PERFORMED AND CONFIRMED A FRACTURE FOUND ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND A NEW DF-4 LEAD WAS IMPLANTED ALONG WITH A NEW DF-4 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156892 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R 0292| N161| 4087| 4555| N160| H217| 1298| 4088| 0185| N119