BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213153 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10326
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 8, 2013
    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

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    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A SEVERED LEAD, 166MM FROM THE TERMINAL PIN: TWO SEGMENTS WERE RETURNED FOR A TOTAL LENGTH OF 740MM. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN: THE POLY INSULATION SLEEVE WAS BUNCHED IN SEVERAL LOCATIONS. ADDITIONALLY, THE TRILUMEN ABRASION SLEEVE WAS BUNCHED AT 226-228MM FROM THE TERMINAL PIN AND ALSO ABRADED THROUGH AT THIS LOCATION. THE POLY SLEEVE AND TRILUMEN INSULATION ARE INTACT. THE CLEAR MEDICAL ADHESIVE WAS TORN/SEPARATED FROM THE GORE AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED AT THIS POINT. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. THE HELIX WAS EXTENDED, WITH BLOOD AND/OR BODY FLUID PRESENT. THE RETURNED LEAD SEGMENTS PASSED ELECTRICAL TESTING. ANALYSIS COULD NOT CONFIRM UNDERSENSING. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT APPEARS THAT THE ABRASION WAS MOST LIKELY DUE TO LEAD-ON-LEAD INTERACTION.

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SYSTEM WAS HOSPITALIZED FOR A NON-CARDIAC RELATED CONDITION. DURING HOSPITAL ADMISSION, THE PATIENT REPORTEDLY EXHIBITED A VENTRICULAR FIBRILLATION (VF) RATE; HOWEVER, THE DEVICE FAILED TO DELIVER THERAPY. EXTERNAL DEFIBRILLATION AND CPR WERE PERFORMED: SYSTEM UNDERSENSING WAS SUSPECTED. ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN MISPLACED THE PRINTED EPISODES, THUS NO TECHNICAL REVIEW WAS PERFORMED. DURING A SUBSEQUENT DEVICE INTERROGATION, NO EPISODES FROM THIS DATE (OR SURROUNDING DATES) WERE OBSERVED. THE RIGHT VENTRICULAR LEAD, ALONG WITH THE DEVICE, WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANOTHER SYSTEM WAS IMPLANTED WITH FAVORABLE MEASUREMENTS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312359 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R