BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2983629 · Received February 28, 2013

    Report

    Report Number
    2182208-2013-00476
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 30, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE VERIFIED ON X RAY. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR(RV) LEAD IMPEDANCE WAS HIGH AND THAT THERE WAS NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86160 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Hospitalization| R