BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2881321 · Received December 20, 2012

    Report

    Report Number
    2182208-2012-04196
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 7, 2012
    Report Date
    April 10, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S FIELD REPRESENTATIVE DOCUMENTS HIGH RATE EPISODES ATTRIBUTED TO OVERSENSING AND NOISE WERE NOTED DURING ISOMETRICS AT THE PATIENT'S FOLLOW-UP APPOINTMENT. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE LEAD WAS NOT ANALYZED AS IT REMAINS CAPPED AND IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    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 BY THE PATIENT'S FAMILY MEMBER THAT THE LEAD REQUIRES REPLACEMENT AND THE "WIRE WAS BROKEN WITHIN THE PLASTIC COATING." ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN'S OFFICE NOTED THAT THE ATRIAL LEAD IS FRACTURED. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE LEAD REQUIRES REPLACEMENT AND THE "WIRE WAS BROKEN WITHIN THE PLASTIC COATING". ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN'S OFFICE NOTED THAT THE ATRIAL LEAD IS FRACTURED. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Hospitalization| R 5816 COMPETITOR IMPLANTABLE PULSE GENERATOR