BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851722 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14071
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND SURGICALLY ABANDONED AFTER EXHIBITING LOSS OF CAPTURE AND INCREASED PACING THRESHOLDS. IT SUBSEQUENTLY WAS REPORTED THAT THE LEAD HAD EXPERIENCED A FRACTURE DUE TO CLAVICULAR CRUSH. THERE WERE NO ADVERSE PATIENT EFFECTS, AND ANOTHER RV LEAD WAS IMPLANTED.

    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 59 YR Required Intervention 0185| 4087| T167