BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864158 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16056
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 9, 2010
    Report Date
    April 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SENT TO THE EXPLANTING FACILITY'S PATHOLOGY DEPARTMENT. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE LEAD IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE LEAD IS EXPLANTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS CAPPED, SURGICALLY ABANDONED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS. THE LEAD'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO THE ASSOCIATED SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS EXPLANTED 8.6 MONTHS LATER DUE TO A PATIENT INFECTION. IT WAS REPORTED THE PATIENT EXPERIENCES RECURRENT (B)(6).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ASSOCIATED WITH A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. A HEALTH CARE PROVIDER (HCP) REPORTED THE IMPEDANCE MEASUREMENTS HAD BEEN TRENDING UPWARD SINCE IMPLANT 14 MONTHS PREVIOUS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED TROUBLESHOOTING STRATEGIES. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    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 Other N119| 4047| 0185| 4470