BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3153119 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05824
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCTS: 6947 IMPLANTABLE TACHY LEAD - (B)(6) 2008; 5524M IMPLANTABLE PACING LEAD - (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD EXHIBITED NOISE AND OVERSENSING. IT WAS SUSPECTED THAT THE LEAD WAS SENSING THE PATIENT'S ATRIAL FIBRILLATION (AF). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256019 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR D314DRG IMPLANTABLE DEFIBRILLATOR