BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140029 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16563
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2004
    Report Date
    September 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE INFORMATION KNOWN AT THIS TIME. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, APPROXIMATELY TEN YEARS LATER, IT WAS THOUGHT THE REPLACEMENT (NON-BOSTON SCIENTIFIC) LEAD WAS FRACTURED. A FURTHER REVISION WAS PERFORMED. THIS LEAD WAS REUSED AS THE HIGH VOLTAGE LEAD AND THE COMPETITOR LEAD WAS USED FOR PACE/SENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THIS SURGICALLY ABANDONED LEAD. REPORTEDLY, THIS LEAD WAS PREVIOUSLY REPLACED WITH A NON-BOSTON SCIENTIFIC LEAD DUE TO FAR-FIELD OVERSENSING AND PACING INHIBITION. CURRENTLY, THE REPLACEMENT LEAD IS SUSPECTED FRACTURED. TS WAS CONTACTED FOR THEIR OPINION WHETHER THIS LEAD COULD BE REUSED AS THERE ARE ACCESS ISSUES WITH IMPLANTS. TS PROVIDED OPTIONS FOR REUSE OF THE LEAD AND RECOMMENDED THE THAT LEAD INTEGRITY BE VERIFIED PRIOR TO REUSING THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620277 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R 4017| 4087| 1853| 1861| 0158| 0155