BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 1991849 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02584
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 PUERTO RICO, INC. 4011 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 8423 IMPLANTABLE PULSE GENERATOR