BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3771534 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-04827
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    February 16, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION OF THE LEAD WAS PERFORMED. ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. THE LEAD PASSED THE CONTINUITY AND HIPOT TESTS. FIELD OBSERVATIONS WERE NOT CONFIRMED THROUGH TESTING ON RETURNED SEGMENT OF THE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE RV LEAD WAS SURGICALLY ABANDONED DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE ICD WAS ALSO EXPLANTED DURING THE PROCEDURE DUE TO AN UPGRADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA THE PATIENT¿S REMOTE HOME MONITORING SYSTEM THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE IMPEDANCE MEASUREMENTS OF THE RV LEAD HAD INCREASED FOR THE PAST FIVE YEARS. THE DEVICE FUNCTION AND PACING PARAMETERS WERE STILL IN NORMAL RANGE AS OF THE CURRENT EVALUATION. THE PATIENT WAS SENT FOR SYSTEM UPGRADE AND DID QUALIFY UPON SCREENING. AT THIS TIME, THE PATIENT WILL FOLLOW-UP WITH THE FACILITY THAT IS CAPABLE FOR THE SYSTEM UPGRADE. THE SYSTEM REMAINS IN SERVICE. NO 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
    248658 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 0158| E141| 1860