BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4163276 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12394
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    April 10, 2012
    Report Date
    August 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: 5076-58 LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS ENROLLED IN THE OBSERVE CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATRIAL ELECTRODE FRACTURE AND DISLODGEMENT OF VENTRICULAR ELECTRODE HISTORY: UNKNOWN INJURY: NO INTERVENTION REQUIRED: NEW SURGERY TO REPOSITION VENTRICULAR ELECTRODE AND REPLACE ATRIAL ELECTRODE OUTCOME: ALIVE - NO INJURY, EVENT RESOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643940 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ADDR01 IPG