BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3935993 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13897
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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).

    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 THIS PATIENT WAS PLANNED TO BE IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND WAS PART OF A STUDY IN WHICH A MYOCARDIAL BIOPSY WAS PERFORMED. THE BIOPSIES WERE TAKEN PRIOR TO THIS RIGHT VENTRICULAR (RV) LEAD BEING PLACED INTO THE PATIENT'S VASCULATURE. AFTER THE RV LEAD WAS IMPLANTED A PACING THRESHOLD MEASUREMENT TEST WAS STARTED BUT TERMINATED HAD TO BE TERMINATED AS THE PATIENT EXPERIENCED PACEMAKER MEDIATED TACHYCARDIA. SHORTLY THEREAFTER, A DROP IN BLOOD PRESSURE WAS OBSERVED THAT WAS FOUND TO BE THE RESULT OF A PERICARDIAL EFFUSION SECONDARY TO PERFORATION. A PERICARDIAL PUNCTURE WAS PERFORMED TO STABILIZE THE PATIENT AND THE LEAD EXPLANTED TO AVOID POSSIBLE INFECTION. THE PATIENT'S WOUND WAS CLOSED AND THEY WERE TRANSFERRED FOR RECOVERY. IT IS UNKNOWN IF THE PRE-LEAD IMPLANT BIOPSY OR THE IMPLANT PROCEDURE FOR THE LEAD RESULTED IN THE PERFORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS NEVER IN SERVICE AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413897 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI PLANT - ST. PAUL 0693

    Patients

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