BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053265 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04588
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED AND SLIGHTLY STRETCHED. A HELIX MECHANISM TEST WAS UNDERTAKEN. THE HELIX FUNCTIONED NORMALLY; HOWEVER, DUE TO IT BEING STRETCHED, DID NOT FULLY RETRACT WITHIN THE HOUSING. DEPENDING UPON WHEN THIS DAMAGE OCCURRED, THIS FINDING COULD HAVE CONTRIBUTED TO DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED FOLLOWING THE IMPLANT PROCEDURE. A REVISION WAS PERFORMED; HOWEVER, THE HELIX WAS NOT ABLE TO BE RETRACTED. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER LEAD. 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
    155510 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R