BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964553 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02113
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PRODUCT : 310F29 TISSUE VALVE (B)(6) 2004; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE "DEVICE HAS BEEN BEEPING" DUE TO A "BROKEN WIRE." THE PATIENT HAS BEEN TO THE PHYSICIAN AND STATED THE PHYSICIAN SAID "NOT TO WORRY ABOUT IT." FOLLOW-UP WITH THE PHYSICIAN CLARIFIED THAT THERE IS NO LEAD FRACTURE AND THE PATIENT ALERT WAS CAUSED BY LOW IMPEDANCE ON THE RIGHT ATRIAL LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68099 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D274DRG IMPLANTABLE DEFIBRILLATOR