BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 219202 · Received April 14, 1999

    Report

    Report Number
    1723248-1999-00200
    Event Type
    Injury
    Date Received
    April 14, 1999
    Date of Event
    September 15, 1994
    Report Date
    April 14, 1999
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. NOTE: THIS REPORT WAS RECEIVED 2/12/1999. THE EVENT DATE IS PRIOR TO THE RECALL OF THE ACCUFIX LEADS. NO SUCH CLASSIFICATIONS WERE ESTABLISHED PRIOR TO 10/1994. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION, DIRECT TRACTION WITH LOCKING STYLET, INTRAVASCULAR COUNTER TRACTION, SHEATH(S). NO COMPLICATIONS.

    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 76 YR Required Intervention