BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4832283 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05112
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO SUSPECTED LEAD FRACTURE, STIMULATION IMPEDANCE INCREASED, DETERIORATION OF SENSING AND INCREASE OF THRESHOLD. IT WAS ALSO REPORTED THAT IMPAIRMENT OF ATRIAL LEAD LIKELY BY MEANS OF REVISION OF RV LEAD, THUS THE LEAD WAS ALSO EXPLANTED 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
    379932 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 5076 LEAD, REDR01 IPG