BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131502 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13755
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 27, 2014
    Report Date
    August 12, 2014
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 DEVICE DELIVERED AN INAPPROPRIATE SHOCK. DURING A FOLLOW-UP, RADIOGRAPHY CONFIRMED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS IN THE ATRIUM. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611382 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI PLANT - ST. PAUL 0695

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0695