BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990749 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08508
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CONCOMITANT PRODUCT: 5076-45 LEAD, IMPLANTED (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO ASYSTOLIC EPISODES WHICH WERE NOTED ON TELEMETRY WHILE THE PATIENT WAS IN THE HOSPITAL FOR AN UNRELATED FALL. INTERROGATION OF THE DEVICE SHOWED NORMAL PARAMETERS FOR THE RIGHT VENTRICULAR LEAD; THE CAUSE OF THE "NO OUTPUT" COULD NOT BE IDENTIFIED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE RIGHT VENTRICULAR 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
    472214 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| L| R SDR303B IPG