BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1875216 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11644
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    May 25, 2010
    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
    MO, 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: (B)(4) DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. WITHOUT A LOT NUMBER OR LEAD SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM WAS REMOVED DUE TO INFECTION. SURGICAL NOTES RECEIVED REPORTED THAT PRIOR TO THE SYSTEM REMOVAL, THE PATIENT HAD COMPLAINED OF FLU-LIKE SYMPTOMS AND BLOOD DRAINAGE FROM THE IMPLANT SITE. PATIENT TREATED WITH INTRAVENOUS ANTIBIOTICS AND CULTURES CAME BACK POSITIVE FOR (B)(6). THE WOUND HEALED NICELY. ADDITIONAL INFORMATION WAS ALSO RECEIVED INDICATING THAT DURING THE INITIAL IMPLANT OF THIS SYSTEM BACK ON (B)(6) 2010, THE PATIENT HAD INCREASED CHEST TUBE DRAINAGE SECONDARY TO A LEFT PLEURAL EFFUSION THAT WAS DISCOVERED INTRAOPERATIVELY. A HEMATOMA OVER THE DEVICE POCKET AND A SMALL PNEUMOTHORAX WERE ALSO NOTED. THERE WAS ALSO REFERENCE TO A (B)(6) 2009 IMPLANT ATTEMPT WHERE A CS LEAD WAS UNABLE TO BE PLACED DUE TO INAPPROPRIATE PACING & THRESHOLDS SO A CS LEAD WAS NOT USED. FOLLOW-UP ATTEMPTS WERE UNABLE TO OBTAIN ADDITIONAL SPECIFIC INFORMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 61 YR Required Intervention