BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2964456 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02114
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRODUCT: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROUTINE CHEST X-RAY THE DAY OF IMPLANT REVEALED A SMALL LEFT PNEUMOTHORAX WHICH WAS BEST APPRECIATED ALONG THE LATERAL ASPECT OF THE HEMITHORAX. THE IMPLANTER INDICATED THAT THERE WAS DIFFICULTY OBTAINING VENOUS ACCESS. A REPEAT CHEST X-RAY WAS DONE BEFORE THE PATIENT WAS DISCHARGED THAT NOTED THE PNUEMOTHORAX WAS SLIGHTLY SMALLER. THE LEADS ARE STILL IN USE. IT WAS NOTED THAT THE PATIENT WAS PART OF THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67176 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Life Threatening RVDR01 IMPLANTABLE PULSE GENERATOR