BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3152383 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01563
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 4, 2010
    Report Date
    March 13, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT MEDICAL PRODUCTS: T20A2U IMPLANTABLE PULSE GENERATOR (IPG): (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPOSITIONED TO THE LOW SEPTUM. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. THE LEAD REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE PANORAMA OBSERVATIONAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252998 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG ICQ09B

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R