BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 7409077 · Received April 9, 2018

    Report

    Report Number
    2124215-2018-04483
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    February 23, 2018
    Report Date
    June 11, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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 REVEALED SUPERFICIAL CUTS IN THE INSULATION THAT WERE LIKELY INDUCED DURING THE EXPLANT PROCEDURE. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES GREATER THAN 200 OMHS. A REVISION PROCEDURE WAS PERFORMED, AND THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251985 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0158| D021