BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3050920 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04729
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 2, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE LEAD HAD APPARENT EXPLANT DAMAGE. PRODUCTS: ADDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2008; 5568 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR EARLY. ALSO REPORTED WAS CHRONIC HIGH THRESHOLD OF THE RIGHT VENTRICULAR (RV) LEAD WITH EXIT BLOCK. THE DEVICE AND THE RV LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150010 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R