BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4970159 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08672
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: VEDR01, IPG, IMPLANTED: (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH EPISODES OF SYNCOPE DUE TO INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV OUTPUT WAS INCREASED AND NO FURTHER EPISODES OF NON-CAPTURE WERE OBSERVED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. X-RAY SHOWED LACK OF SLACK ON THE RA AND RV LEADS, AND IT WAS FELT THAT THE LOSS OF CAPTURE WAS DUE TO THE SLACK ISSUE, REQUIRING HIGHER THRESHOLDS AT CERTAIN POSITIONS. THE LEADS WERE CAPPED AND REPLACED TWO DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE OLD SYSTEM HAD BEEN INACTIVATED WHEN THE NEW SYSTEM WAS IMPLANTED. THE LEADS WERE LATER CAPPED AND THE DEVICE EXPLANTED. IT WAS ALSO REPORTED THAT THE RV LEAD HAD HIGH THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512601 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| L| R