BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 3992723 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09703
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCTS: 5568-53 LEAD IMPLANTED: 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO EXHIBITING NO CAPTURE AND UNSTABLE THRESHOLDS. THE LEAD ALSO CONTAINS A POSSIBLE LEAD FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470449 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICF09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R T60A1B IPG