BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK MINI

    MDR report key: 2162494 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06962
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    LWS
    PMA / PMN Number
    P910077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PRODUCT SUFFERED FROM A DEVICE POCKET INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS HISTORICAL CPI ST. PAUL 1746

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 1746| 0040| 0041| 0030| 1520| 1550