BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2368521 · Received December 12, 2011

    Report

    Report Number
    2182208-2011-02995
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    March 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KFJ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEADS WERE EXPLANTED AND REPLACED. 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 NONE MEDICAL ADHESIVE KFJ MEDTRONIC, INC. 080118 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| 2872 IMPLANTABLE LEAD ADAPTOR