BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2208167 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01494
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED 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: "DISSEMINATED MALIGNANCIES MASQUERADING AS CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES INFECTIONS." EUROPACE. JUNE 1 2011;13(6):821-824.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THE DEVICE AND LEADS. THE PATIENT PRESENTED WITH SWELLING OF THE ICD GENERATOR POCKET. A DIAGNOSIS OF POCKET INFECTION WAS MADE AND THE PATIENT WAS SCHEDULED FOR DEVICE AND LEAD REPLACEMENT. DURING THE EXTRACTION PROCEDURE, THE POCKET LOOKED FREE FROM INFECTION, BUT TISSUE SAMPLES WERE TAKEN AND SENT TO PATHOLOGY. THERE WAS ALSO NOTED TISSUE OVER THE ICD POCKET. PER THE AUTHOR, THE RESULTS WERE "CONSISTENT WITH STAGE II DIFFUSE LARGE-CELL LYMPHOMA." THE SYSTEM WAS REPLACED AND THE PATIENT WAS REFERRED TO THE ONCOLOGY SERVICE AND BEGAN RECEIVING CHEMOTHERAPY, WITH GOOD RESPONSE. 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 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R