BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2933777 · Received January 29, 2013

    Report

    Report Number
    2182208-2013-00012
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 3, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT PRODUCT: 4965 IMPLANTABLE PACING LEAD, 2008-(B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    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 RIGHT ATRIAL (RA) LEAD WAS UNABLE TO CONSISTENTLY CAPTURE. THE PATIENT IS SCHEDULED TO HAVE THE RA LEAD REVISED AND THE LEAD REMAINS IN USE AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON 2013-(B)(6), IT WAS LATER NOTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD WERE OVERSENSING. BOTH THE RA AND RV LEADS WERE CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38893 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)