BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4163142 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12452
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 PRODUCTS: DDMB1D4 ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN ONE WEEK OF IMPLANT, THE PATIENT WAS ADMITTED FOR ATYPICAL CHEST PAIN AND SHORTNESS OF BREATH, WORSENING WITH DEEP INSPIRATION. ECHOCARDIOGRAPHIC STUDY REVEALED A SMALL PERICARDIAL EFFUSION, WITH PERICARDITIS ALSO NOTED. ALL OTHER LABS AND CHEST X-RAY WERE WITHIN NORMAL LIMITS. THE PATIENT WAS GIVEN MEDICATION AND DISCHARGED IN STABLE CONDITION TWO DAYS LATER. THE PATIENT RETURNED TWO DAYS AFTER THAT WITH WORSENING SHORTNESS OF BREATH, PLEURITIC CHEST DISCOMFORT, AND LIGHTHEADEDNESS. ECHOCARDIOGRAM CONFIRMED PERICARDIAL EFFUSION. ADDITIONAL MEDICATION WAS PROVIDED, AND PERICARDIOCENTESIS WAS PERFORMED TWICE. THE INVESTIGATOR CLASSIFIED THE EVENT AS RELATED TO THE IMPLANT PROCEDURE, WITH UNKNOWN RELATEDNESS TO THE LEADS. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LEADS WERE NOTED TO BE PART OF THE EVERA MRI STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644856 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R 6935M62 LEAD