BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132264 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17008
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 13, 2013
    Report Date
    July 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE THIS DEVICE AND LEAD REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IT WAS REPORTED THE PATIENT WAS LOST TO FOLLOW-UP AND HIGH OUT OF RANGE MEASUREMENTS WERE OBSERVED AS FAR BACK AS A YEAR. AN INVASIVE PROCEDURE WAS PERFORMED AND IT WAS DETERMINED THE MEASUREMENTS WERE CAUSED BY A LOOSE CONNECTION. THE SETSCREW WAS RETIGHTENED WHICH RESOLVED THE CLINICAL OBSERVATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612619 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 0157| E102