BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2053587 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00546
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4): A FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. ADDITIONAL OBSERVATIONS OF PROXIMAL CONDUCTOR DISTORTED AND DAMAGED AT IMPLANT. STYLET WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. ADDITIONAL OBSERVATION OF STYLET BENT AND DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT WHEN THE PHYSICIAN INSERTED THE STYLET INTO THE RIGHT ATRIAL LEAD, THE LEAD BODY DISTORTED, THE OUTER COIL OF THE LEAD STRETCHED AND THE STYLET LODGED IN THE LEAD BODY. IT WAS ALSO NOTED THAT THERE WAS AN APPARENT LEAD FRACTURE. THE LEAD INTEGRITY COULD NOT BE ASSURED SO THE LEAD WAS NOT IMPLANTED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE STYLET DRB MEDTRONIC, INC. STYLET ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other