BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2965054 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01917
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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).

    Additional Manufacturer Narrative · 1

    (B)(4): THE FILE IS BEING RESUBMITTED DUE TO AN ISSUE WITH ESG/FDA. EVALUATION SUMMARY: THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. HOWEVER, IT WAS NOTED THAT BLOOD WAS PRESENT ON THE DISTAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS NOT IMPLANTED DUE TO UNDERSENSING. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS NOT IMPLANTED DUE TO UNDERSENSING. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69122 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention