BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLENCE PS+

    MDR report key: 4832248 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05090
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT MEDICAL PRODUCT: VEDR01 IPG, IMPLANTED: 2008-(B)(6); (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTED BLOOD IN THE RIGHT VENTRICULAR (RV) LEAD AT THE SITE OF THE SUTURE SLEEVE. IN ADDITION, A LOW IMPEDANCE MEASUREMENT WAS OBSERVED WITH THE RV LEAD. THE PHYSICIAN IDENTIFIED A NICK IN THE LEAD INSULATION. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379508 EXCELLENCE PS+ ELECTRODE, PACEMAKER, PERMANENT DTB MPRI IMK49B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R (B)(4) LEAD