BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2812302 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03745
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO UPGRADE THE PATIENT TO A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE THE CHRONIC LEFT VENTRICULAR (LV) LEAD APPEARED TO BE FRACTURED. ONCE THE LV LEAD WAS FREED FROM THE TISSUE, IT WAS EVIDENT THAT THE LV LEAD HAD BROKEN OFF. THE REMAINING PORTION OF THE LV LEAD INSIDE THE POCKET WAS CAPPED AND REPLACED WITH A NEW LEAD. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR