BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3994056 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08998
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: D224TRK DEVICE, IMPLANTED: (B)(6) 2010; 5071-35 LEAD, IMPLANTED: (B)(6) 2003; 407658 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT CAPTURE AT MAXIMUM OUTPUT SETTINGS WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. EVALUATION OF ASSOCIATED DEVICE DATA SHOWED RECORDED EPISODES OF ATRIAL HIGH RATES (AHR) WHICH APPEARED TO BE DUE TO OVERSENSING OF NON-PHYSIOLOGIC NOISE BY THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED DURING A ROUTINE DEVICE CHANGEOUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469605 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 694765 LEAD