BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140022 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16393
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 5, 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). 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 SHORTLY AFTER IMPLANT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. WHEN THE PATIENT PRESENTED, LOSS OF CAPTURE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD AND HIGH THRESHOLD MEASUREMENTS ON THE LEFT VENTRICULAR (LV) LEAD. X-RAY INDICATED THAT THE RV LEAD HAD DISLODGED AND WHILE THE LV LEAD WAS STILL IN THE TARGET VESSEL IT HAD MOVED MORE PROXIMAL. DURING THE REVISION PROCEDURE, A SPACE WAS NOTED BETWEEN THE RV SUTURE SLEEVE AND THE PUNCTURE SITE. THE RV LEAD WAS STILL SECURED IN THE SLEEVE; HOWEVER, A LARGE PART OF THE LEAD WAS IN THE POCKET. IT WAS SUSPECTED THE FORCE OF THE RV LEAD IN COMBINATION WITH THE FRICTION BETWEEN THE RV AND LV LEADS RESULTED IN THE DISLODGEMENT OF BOTH LEADS. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. THE LV LEAD WAS ATTEMPTED TO BE REPOSITIONED WITH A GUIDEWIRE WITH NO SUCCESS. THE ORIGINAL PUNCTURE SITE COULD NOT BE USED DUE TO FIBROTIC TISSUE. THEREFORE, A NEW PUNCTURE WAS MADE AND A NEW LV LEAD WAS ATTEMPTED. THE ORIGINAL TARGET VESSEL HAD THROMBOSIS AND THE OTHER OPTIONS HAD POOR MEASUREMENTS. AFTER NEARLY TWO HOURS, THE PHYSICIAN DECIDED TO PLACE THE LEAD IN A PROXIMAL ANTERIOR VESSEL. THE THRESHOLD MEASUREMENTS WERE HIGH IN ALL BUT ONE CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619664 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI PLANT - ST. PAUL 0693

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4677| 7741| 0693| G179