BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4834172 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06770
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN AND A POSSIBLE PERICARDIAL EFFUSION. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE BOTH REPOSITIONED. THE PATIENT INDICATED THAT THEY HAD RELIEF FROM THE PAIN AFTER THE RV LEAD WAS REPOSITIONED. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378065 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| L| R (B)(4) IPG, (B)(4) LEAD