BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946157 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20522
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RECENT CLINICAL FOLLOW-UP, THIS DEVICE EXHIBITED SHOCK IMPEDANCES OF GREATER THAN 125 OHMS. THE PHYSICIAN PERFORMED AN R-WAVE SYNCHRONOUS SHOCK TEST, WITH A RETURNED IMPEDANCE OF 99 OHMS. FURTHER EVALUATIONS VIA LIT TESTING, RETURNED VALUES BETWEEN 121-123 OHMS. WHILE NO ADVERSE PATIENT EFFECTS WERE REPORTED, THE PHYSICIAN ELECTED TO MONITOR THE CONDITION. ADDITIONALLY, A DATA DISK WAS SENT TO BSC EURO-TECHNICAL SERVICES FOR EVALUATION. DISK ANALYSIS CONFIRMED INTERMITTENT DAILY SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS; HOWEVER, NOTHING TO INDICATE A LEAD INTEGRITY ISSUE AT THIS TIME. RECOMMENDATION FOR INCREASED FOLLOW-UP WAS COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P107| 4542| 0181| 4480