BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1991951 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02649
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY: PNP493593H: NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADAPTOR WAS DAMAGED DURING A DEVICE CHANGE OUT PROCEDURE. THE ADAPTOR WAS REMOVED AND REPLACED. IT WAS SUBSEQUENTLY REPORTED BY THE PATIENT THAT THE DEVICE REPLACED DURING THE CHANGE-OUT PROCEDURE WAS "LEAKING" AND THAT THE LEADS HAD BEEN WRAPPED AROUND THAT DEVICE. THE DEVICE WAS REMOVED AND REPLACED AND ALL THREE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O| R