BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3153290 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05920
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. A E2DR01AA IMPLANTABLE PULSE GENERATOR (IPG), (B)(6) 2005. A 5076-52 IMPLANTABLE PACING LEAD. (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD LOW IMPEDANCE AND HAD NO CAPTURE. THE LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256200 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R