BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211034 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09729
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION REVEALED THAT MEDICAL ADHESIVE WAS TORN/SEPARATED FROM THE GORE AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED AT THAT POINT. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. BLOOD/BODY FLUID WAS NOTED IN THE RS-LUMEN AND THE HELIX HOUSING. THE LEAD BODY WAS TWISTED AT THE DISTAL END AND THE HELIX WAS RETRACTED. ALL OF THE DAMAGE NOTED DURING VISUAL INSPECTION APPEARED TO BE RELATED TO THE EXPLANT PROCEDURE. DETAILED ANALYSIS REVEALED AN INSULATION ABRASION ON THE IS-1 TERMINAL LET THROUGH TO THE RS+ CONDUCTOR COIL AT 77-82 MILLIMETERS (MM) FROM THE TERMINAL PIN. BOTH THE INSULATION AND INSULATION SLEEVE WERE ABRADED THROUGH. THE MORPHOLOGY OF THE INSULATION BREACH WAS INDICATIVE OF LEAD-ON-CAN CONTACT. MELTED METAL WAS EVIDENT ON THE RS+ CONDUCTOR COIL UNDERNEATH THIS ABRASION SITE. THE RS+ CONDUCTOR COIL WAS CONTINUOUS IN THIS AREA. THERE ALSO WAS A DEEP SURFACE INSULATION ABRASION ON THE IS-1 LEG ON THE OPPOSITE SIDE OF THE LEAD-ON-CAN ABRASION WHICH RAN FROM 76-82 MM, BUT WAS NOT THROUGH THE INSULATION. THERE WERE OTHER DEEP SURFACE ABRASIONS NOTED ON BOTH THE PROXIMAL HV AND DISTAL HV TERMINAL LEGS IN THIS AREA AS WELL AS ON THE LEAD JUST DISTAL OF THE YOKE. THE ABRASIONS APPEARED TO SPIRAL AROUND THE LEAD AND ARE MOST LIKELY DUE TO LEAD-ON-LEAD INTERACTION WITHIN THE POCKET AREA. THE CLINICAL OBSERVATION WAS ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WAS SEEN FOR A DEVICE INTERROGATION. THE PATIENT'S PHYSICIAN REPORTED TO THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) THAT, UPON INTERROGATION, THE DEVICE DISPLAYED THREE FAULT CODES INDICATING A SHORTED CAPACITOR CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A DEVICE CHANGE-OUT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT DEVICE/LEAD CONNECTION APPEARED INTACT. SLIGHT DIVETS WERE NOTED ON THE FRONT AND THE BACK OF THE CAN. OF NOTE, FORCEPS WERE NOT USED TO REMOVE THE DEVICE FROM THE POCKET. A NEW DEVICE WAS IMPLANTED WITH THE CHRONIC RV LEAD AND ALL LEAD DIAGNOSTICS WERE WITHIN RANGE. A 41 JOULE SHOCK WAS THEN DELIVERED. A POPPING SOUND WAS HEARD AND THE DEVICE THEN DISPLAYED A FAULT CODE FOR A SHORTED CONDITION. THE CAN WAS REMOVED FROM THE POCKET AND DIVETS WERE SEEN THAT WERE SIMILAR TO WHAT WAS SEEN ON THE PREVIOUSLY EXPLANTED CAN. THE RV LEAD WAS THEN EXPLANTED AND A NEW RV LEAD AND DEVICE WERE IMPLANTED WITHOUT FURTHER COMPLICATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ALL PRODUCTS HAVE BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311168 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0184| 4054| E110