BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 2811794 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03832
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K832099
    Removal / Correction Number
    M-002-2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    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 THERE WAS LEAD WARNING FOR LOW IMPEDANCE MEASUREMENT ON THE RIGHT ATRIAL LEAD. IT WAS NOTED THAT THE UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4012

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5026 IMPLANTABLE PACING LEAD