BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051549 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04869
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE WHICH INDICATED STRETCHING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONTINUATION: D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6); 4194 LEFT VENTRICULAR (LV) LEAD IMPLANTED: 2009-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE GENERATOR CHANGE THE ATRIAL LEAD PULLED BACK. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148994 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD