BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212685 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08955
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED CUTS IN THE INSULATION 210 MM FROM THE TERMINAL PIN AND IN THE SUTURE SLEEVE. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE AND PROXIMAL END OF THE DISTAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION. BLOOD AND BODY FLUID WAS NOTED THROUGHOUT THE HELIX MECHANISM. ANALYSIS CONCLUDED THAT THE RATE SENSE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 214 MM FROM THE TERMINAL PIN AND ALSO AT 220MM FROM THE TERMINAL PIN. DUE TO THE LOCATION OF THE FRACTURE ANALYSIS DETERMINED IT WAS CONSISTENT WITH FATIGUE FRACTURE AT THE SUTURE SLEEVE TIE DOWN AREA.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. REVIEW OF THE DATA REVEALED DIFFERENT NON-SUSTAINED EPISODES AND ONE ATP DELIVERED FOR VENTRICULAR FIBRILLATION (VF). IT WAS DETERMINED THERE WAS RIGHT VENTRICULAR LEAD NOISE. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD REVEALED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    - -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314485 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 0185| P107