BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132222 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15369
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, VESSEL PERFORATION OCCURRED; HOWEVER, NOT CONFIRMED THROUGH X-RAY AND ECHO, UNTIL AFTER POCKET CLOSURE. DURING THE REVISION, A FEW DAYS POST-IMPLANT, THE RV LEAD WAS SUCCESSFULLY REMOVED AND THE PERFORATION SITE SEWN. ANOTHER LEAD WAS IMPLANTED: NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED LEAD WAS DISCARDED. NO ALLEGATIONS THE PRODUCT WAS A CONTRIBUTOR TO THIS CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613096 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI PLANT - ST. PAUL 0693

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0693