BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993465 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09285
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 MEDICAL PRODUCTS: SEDR01 IPG, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER A SYNCOPAL EPISODE DUE TO NON-CAPTURE ON THE RV LEAD. IT WAS ALSO NOTED THAT THERE WERE HIGH THRESHOLDS, HIGH IMPEDANCE, AND VENTRICULAR HIGH RATE EPISODES CONSISTENT WITH LEAD NOISE. FRACTURE WAS SUSPECTED. 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
    469548 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| L| R 5076-52