BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771446 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12551
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 12, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER TROUBLESHOOTING WAS TO BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BEING RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD. AS OF TODAY, NO FURTHER INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE NOISE WAS REPRODUCIBLE AND ONLY LOCATED ON THE SHOCK CHANNEL. THE DEVICE WAS IMPLANTED INTRA-PECTORAL AND THE PHYSICIAN FELT THE HEADER MAY BE LOOSE. THE PHYSICIAN HAD ELECTED TO REPLACE BOTH THE DEVICE AND THE LEAD. WARRANTY WAS DISCUSSED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE IMPEDANCES HAD ROSE FROM 500 OHMS TO > 2000 OHMS. THERE WAS REPORT OF POSSIBLE LEAD FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A HIGH PACING IMPEDANCES ON THIS DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention E102| 0157