BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 3051052 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-00940
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ADSR01 IMPLANTED: 2008-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE PATIENT WAS PART OF THE (B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152250 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R