BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3024334 · Received March 27, 2013

    Report

    Report Number
    2182208-2013-00493
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THERE IS NO INDICATION OF WHICH LEAD IS "BROKEN" OR WHAT IS MEANT BY THE TERM "BROKEN." THE "BROKEN" LEAD WILL BE REFLECTED BY THE MODEL AND SERIAL NUMBER OF THE PATIENT'S RIGHT VENTRICULAR PACING LEAD FOR REPORTING PURPOSES. AS THE PATIENT WAS SEEN IN THE HOSPITAL AND THE PATIENT'S PACEMAKER WAS RETURNED TO THE MANUFACTURER, IT IS REASONABLE TO SUGGEST THERE WAS SURGICAL INTERVENTION, AND THE AFFECTED LEAD WAS REPLACED. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. PRODUCT ID ADDR01 IMPLANTABLE PULSE GENERATOR, IMPLANTED: (B)(6) 2011; PRODUCT ID 4965-25 IMPLANTABLE PACING LEAD (B)(6) 2006. THE LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER. (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 BY THE HOSPITAL THE PACING LEAD WAS "BROKEN." THE STATUS OF THE LEAD HAS BEEN REQUESTED AND NOT RECEIVED; HOWEVER,THE INITIAL INFORMATION RECEIVED INDICATED THE PATIENT HAD BEEN ADMITTED FOR A CARDIOVASCULAR PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125873 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Hospitalization| R