BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE

    MDR report key: 1802842 · Received August 17, 2010

    Report

    Report Number
    2182208-2010-00583
    Event Type
    Injury
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "LEFT HEMOTHORAX: A PRESENTATION OF A LATE VENTRICULAR PERFORATION CAUSED BY AN ACTIVE FIXATION PACING LEAD." INTERNATIONAL JOURNAL OF CARDIOLOGY. JUNE 11;141(3):E43-E46.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THERE WAS LOSS OF CAPTURE, CHEST PAIN, HEMOTHORAX, AND PERFORATION NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS REPORTED TO "HAVE RECOVERED WELL." FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. 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 CRYSTALLINE IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. ICQ09B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention