BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952549 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23275
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 4, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED FOLLOWING RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    DURING SURGICAL INTERVENTION, THE PHYSICIAN TRIED WITHOUT AVAIL, TO REPOSITION THE RV LEAD. AS A RESULT, THE PRODUCT WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC RV LEAD. THE EXPLANTED PRODUCT IS NOT INTENDED TO BE RETURNED FOR POST MARKET EVALUATIONS. IF NEW DETAILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOUR DAYS POST IMPLANT THIS RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE; LEAD DISLODGMENT SUSPECTED. WHILE NO ADVERSE PATIENT EFFECTS WERE REPORTED, SURGICAL INTERVENTION WAS SCHEDULED FOR LEAD REPOSITIONING AND AN INAPPROPRIATE SHOCK WAS REPORTED DUE TO ATRIAL FIBRILLATION.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention