BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2973760 · Received February 22, 2013

    Report

    Report Number
    2182208-2013-00473
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND INTERMITTENT CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78731 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG)