BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3992086 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10056
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. CONCOMITANT PRODUCT: ADDR03 IPG IMPLANTED (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE IN-USE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE EXHIBITING NOISE AND CRACKED INSULATION WAS OBSERVED AT THE REPLACEMENT PROCEDURE. IT WAS ALSO REPORTED THAT A PREVIOUSLY ABANDONED RA AND RV LEAD WERE SEVERELY DAMAGED PRIOR TO REMOVAL AT THE REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    THE THREE IMPLANTABLE PACING LEADS WERE RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED WITH NO REASON FOR REPLACEMENT PROVIDED. THE LEADS SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469404 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 405858

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R 553445 LEAD