BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140185 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17601
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RV LEAD WAS KEPT BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. 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 AN IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE PATIENT AND IT WAS DIFFICULT TO ADVANCE THE LEAD PAST THE TRICUSPID VALVE. A NEW STYLET WAS USED AND THE RV LEAD WAS PLACED SUCCESSFULLY. UNDER FLUOROSCOPY, THE PHYSICIAN NOTED THAT THE DISTAL TIP OF THE RV LEAD WAS FRACTURED. A HIGH PACING IMPEDANCE MEASUREMENT OF OVER 2000 OHMS WAS ALSO OBSERVED. THE PHYSICIAN BELIEVED THAT THE TIP OF THE LEAD WAS CAUGHT BETWEEN THE STYLET AND THE PATIENT¿S TISSUE, WHICH CONTRIBUTED TO THE FRACTURE. THE RV LEAD WAS EXPLANTED AND REPLACED, AND WITH A NEW LEAD, THE REST OF THE IMPLANT PROCEDURE PROCEEDED AS PLANNED. THE OLD RV LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620521 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0282

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4479| 4542| 0282| P162