BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990787 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08481
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRODUCTS: MODEL: 6947M55, LEAD; IMPLANT: (B)(6) 2012; MODEL: 419478, LEAD; IMPLANT: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT IT WAS NOT POSSIBLE TO TEST THE HELIX EXTENSION DUE TO DRIED TISSUE/BODY FLUID IN THE SLEEVE-HEAD PREVENTS THE HELIX FROM EXTENDING AND RETRACTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIMINISHED P-WAVES AND INCREASING THRESHOLDS WERE DISCOVERED ON THE PATIENTS RIGHT ATRIAL (RA) LEAD. THE LEAD WAS EXTRACTED 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
    469841 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R D334TRM, ICD