BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990323 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08673
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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
    OTHER

    Narratives

    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. CONCOMITANT PRODUCT: 5076-45 LEAD, IMPLANTED 2006-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS DUE TO A POSSIBLE RIGHT VENTRICULAR LEAD FRACTURE. THE IMPEDANCE AND CAPTURE THRESHOLD WERE HIGH AND A LEAD WARNING HAD TRIGGERED. AFTER NOTING THE CAPTURE THRESHOLD WAS WITHIN NORMAL LIMITS IN THE UNIPOLAR PACING CONFIGURATION, THE LEAD WAS REPROGRAMMED HOWEVER THE PATIENT DEVELOPED DIAPHRAGMATIC STIMULATION. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463811 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R VEDR01 IPG