BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911895 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16403
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED 21.5 CENTIMETERS (CM) FROM THE IS-1 PIN. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. FATIGUE FRACTURES IN THE POCKET OR CLAVICULAR/FIRST RIB AREA ARE WELL KNOWN AND DOCUMENTED IN THE INDUSTRY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED. 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

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18105 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4555| A135| N119| 0157| 1888TC| E030| 4470