BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXATIP

    MDR report key: 2053443 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00545
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): FULL LEAD RETURNED, ANALYZED AND NO ANOMALIES FOUND. ADDITIONAL FINDINGS OF DEFIB CONDUCTOR DISTORTED, INNER TUBING KINKED/BUCKLED, APPARENT EXPLANT DAMAGE, AND BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ENDOCARDITIS. THE DEFIBRILLATOR AND LEADS WERE REMOVED DUE TO THE INFECTION. THE DEVICE AND LEADS WERE NOT REPLACED AT THE TIME OF EXPLANT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXATIP IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4262 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R