BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP RX

    MDR report key: 1042160 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34479
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP RX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4055 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 0145/302537 WAS IMPLANTED| THE DEVICE 1861/260860 WAS IMPLANTED| THE DEVICE 4096/139916 WAS IMPLANTED| THE DEVICE 4097/118038 WAS IMPLANTED| THE DEVICE T175/132809 WAS IMPLANTED