BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD ADAPTER, 21 CFR 870.3620

    MDR report key: 4656722 · Received April 1, 2015

    Report

    Report Number
    2183787-2015-00035
    Event Type
    Injury
    Date Received
    April 1, 2015
    Date of Event
    February 2, 2015
    Report Date
    March 18, 2015
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K870562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215299 LEAD ADAPTER, 21 CFR 870.3620 BIPOLAR LEAD ADAPTER DTB GREATBATCH MEDICAL 501206 W2464852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention