BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781041 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13318
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE AND LEAD REMAIN IMPLANTED. UPON EXPLANT, THE PRODUCTS WILL BE RETURNED TO BOSTON SCIENTIFIC. UPON RECEIPT, THE PRODUCTS WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE AND LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE WEEKS LATER; THE DEVICE AND LEAD WERE REMOVED AND SUCCESSFULLY REPLACED. THE EXPLANTED PRODUCTS WERE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD UNDERWENT A ROUTINE DEVICE CHANGEOUT. PRIOR TO THE CHANGEOUT, ALL DEVICE AND LEAD MEASUREMENTS WERE NORMAL WITH THE PREVIOUS SYSTEM. THIS NEW ICD HAS REPLACED THE OLD DEVICE AND WAS CONNECTED TO THIS CHRONIC RV LEAD. PRIOR TO DEFIBRILLATION THRESHOLD (DFT) TESTING THE DEVICE WAS TESTED AND ALL MEASUREMENTS WERE NORMAL WITH THE NEW DEVICE. DFT TESTING WAS PERFORMED AND UPON SHOCK DELIVERY A FAULT CODE 1004 WAS EXHIBITED. THE DEVICE STILL CHARGED AND DELIVERED A SHOCK; HOWEVER, THE SHOCK WAS UNSUCCESSFUL AND AN AUDIBLE "POP" WAS HEARD. EXTERNAL CARDIOVERSION WAS THEN PERFORMED TO BRING THE PATIENT BACK INTO HIS CHRONIC RHYTHM. AFTER DFT TESTING, THE DEVICE WAS PACING AND SENSING APPROPRIATELY; HOWEVER, THE SHOCK IMPEDANCES HAD DROPPED TO LESS THAN 20 OHMS. ALL OTHER LEAD PARAMETERS WERE STABLE. A SAVE TO DISK WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES AND ENGINEERING FOR REVIEW. A REVIEW OF THE DISK REVEALED THAT THE DEVICE HAD RECORDED TWO SHOCK LEAD SHORTED FAULTS. THIS WAS DUE TO THE DEVICE SHOCKING INTO A SHORTED LEAD. INSULATION DAMAGE WAS SUSPECTED ON THE LEAD. IT IS LIKELY THAT THE SHOCKS ALSO DAMAGED THE DEVICE AND IT SHOULD BE CONSIDERED COMPROMISED AS DEVICE FUNCTION CANNOT BE GUARANTEED. IT WAS RECOMMENDED TO REPLACE THE DEVICE AND LEAD AS SOON AS POSSIBLE. A REVISION PROCEDURE WAS TO BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 1860| 0148