BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140026 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17278
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    May 6, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED SEVERED 113 MILLIMETERS (MM) FROM THE TERMINAL PIN WITH ONLY THE PROXIMAL SEGMENT RETURNED. RESISTANCE TESTS WERE COMPLETED ON THIS SEGMENT TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD WAS COMPLETELY EXPLANTED DURING A DEVICE CHANGE OUT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. UPON INTERROGATION, A MESSAGE INDICATED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS WAS DETECTED AND ERI WAS REACHED AS WELL. REVIEW OF DAILY MEASUREMENTS REVEALED BOTH PACE AND SHOCK IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. ADDITIONALLY, LOSS OF CAPTURE AT MAXIMUM OUTPUT WAS NOTED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620275 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 1860| 0180| T175