BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140407 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17270
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    November 3, 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). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS DISCOVERED THAT THE LEAD WAS RETURNED SEVERED AND ONLY THE DISTAL SEGMENT OF THE LEAD WAS RETURNED. ELECTRICAL TESTING WAS PERFORMED ON THE SEGMENT OF THE LEAD RETURNED AND THE LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS. AN X-RAY WAS ALSO TAKEN AND NO ANOMALIES WERE NOTED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE CLINICAL OBSERVATION WITH THE RETURNED PORTION OF THE LEAD. EVIDENCE IS SUGGESTIVE THAT THE LEAD WAS CUT DURING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES MEASURING GREATER THAN 2,000 OHMS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED. 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
    618273 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0175| 0185