BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 215914 · Received March 22, 1999

    Report

    Report Number
    1723248-1999-00160
    Event Type
    Injury
    Date Received
    March 22, 1999
    Date of Event
    February 14, 1995
    Report Date
    March 19, 1999
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITH PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. THE PHYSICIAN NOTED A PNEUMOTHORAX WHEN IMPLANTING THE NEW PACING LEAD. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET. COMPLICATIONS LISTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention