BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990678 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08519
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE AND A POSSIBLE FRACTURE. THE LEAD WAS CAPPED 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
    468480 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R REDR01 IPG