BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1991249 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00139
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 30, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PNEUMONIA AND SUBCUTANEOUS EMPHYSEMA SECONDARY TO PNEUMOTHORAX. PATIENT WAS ADMITTED WITH EYES SWOLLEN SHUT AND PLEURAL EFFUSION. THE EPICARDIAL PACER LEAD WAS SEEN EXTENDED IN LEFT CHEST WALL. A NUMBER OF INTERVENTIONS WERE PERFORMED INCLUDING CHEST TUBE PLACEMENT AND A THORACOTOMY FOR DEBRIDEMENT AND DRAINAGE, AND A BRONCHOSCOPY. INTRAVENOUS MEDICATIONS WERE ALSO PROVIDED. THE LEAD IS STILL IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD