BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904768 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10113
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY FACILITY IN VENTRICULAR TACHYCARDIA (VT). THE ICD WAS INTERROGATED AND TWO FAULT CODES WERE REVEALED, SHOCK LEAD SHORTED AND CHARGE TIME EXCEEDED ALONG WITH BATTERY CAPACITY DEPLETED. IT WAS FURTHER REPORTED THAT THE DEVICE POCKET FELT HOT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OBSERVATIONS AND RECOMMENDED THAT THE PATIENT UNDERGO AN IMMEDIATE REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT'S VT WAS MEDICALLY MANAGED AND THEY WERE ADMITTED INTO THE HOSPITAL UNTIL A REVISION PROCEDURE COULD BE PERFORMED. ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THE ICD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND RETURNED NORMAL MEASUREMENTS. FURTHERMORE A 2 JOULE SHOCK WAS PERFORMED WHICH RETURNED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN OPTED TO NOT PERFORM MAXIMUM ENERGY SHOCK TESTING. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382275 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R F110| 0148