BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211521 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08658
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 8, 2013
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION CONFIRMED APPROPRIATE SETSCREW MARKS ON ALL TERMINAL PINS, INDICATING APPROPRIATE LEAD INSERTION INTO THE DEVICE HEADER. BLOOD WAS NOTED IN THE IS-1 TERMINAL PIN OPENING AND DOWN INTO THE RATE/SENSE LUMEN TO APPROXIMATELY 500 MM FROM THE TERMINAL PIN. THE SUTURE SLEEVE WAS POSITIONED BETWEEN THE PROXIMAL AND DISTAL SHOCKING COILS, AND A SURFACE CUT WAS NOTED ON THE INSULATION AND ON THE SUTURE SLEEVE, LIKELY OCCURRING WHEN THE LEAD WAS EXPLANTED. ADDITIONAL EXPLANT DAMAGE WAS OBSERVED ON THE HELIX HOUSING, WHICH APPEARED DEFORMED/FLATTENED. A STYLET WAS SUCCESSFULLY INSERTED INTO THE LUMEN, BUT REQUIRED SLIGHTLY GREATER THAN EXPECTED FORCE TO REMOVE. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEAD¿S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED NOISE AND OVERSENSING.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE AND LEAD ARE EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER POCKET CLOSURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE RV CHANNEL. THE NOISE WAS OVERSENSED, RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE ATP INDUCED VENTRICULAR FIBRILLATION (VF) AND A SHOCK WAS DELIVERED. STRIPS WERE SENT TO A TECHNICAL SERVICES CONSULTANT, WHO DETERMINED THE MORPHOLOGY OF THE NOISE WAS CONSISTENT WITH AIR BUBBLES ESCAPING FROM THE SEAL PLUG. THE POCKET WAS REOPENED AND THE LEAD WAS REMOVED AND RECONNECTED TO THE DEVICE. HOWEVER, WHEN THE PATIENT WAS MOVED, MORE NOISE WAS OBSERVED. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND LEAD AND IMPLANT A NEW SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311226 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R