BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040813 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02061
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS NOT ABLE TO INDUCE VENTRICULAR FIBRILLATION (VF) AT IMPLANT. THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED THAT THE SHOCK ELECTROGRAM DID NOT APPEAR RIGHT. A STRIP WAS SENT IN TO TECHNICAL SERVICES (TS) FOR ANALYSIS. TS STATED THAT THE STRIPS APPEARED TO INDICATED A CONNECTION ISSUE BETWEEN THE LEAD AND PULSE GENERATOR (PG). A REVISION PROCEDURE WAS PERFORMED WHERE IT WAS DISCOVERED THAT THE DEFIBRILLATION TERMINAL PINS WERE REVERSED IN THE HEADER. THE PINS WERE INSERTED IN TO THE CORRECT PORTS WITH RESOLUTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS 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 Required Intervention 4480| (B)(4)| 0185