BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 92864 · Received May 21, 1997

    Report

    Report Number
    1723248-1997-00385
    Event Type
    Injury
    Date Received
    May 21, 1997
    Report Date
    May 20, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY RPT'D UNDER MDR ACCESS NUMBER 706465.

    Description of Event or Problem · 1

    PREVIOUSLY RPT'D AS NO REASON FOR EXPLANT PROVIDED. THE LEAD WAS EXPLANTED DUE TO A RPT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: INTRAVASCULAR COUNTER TRACTION, LASER. 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 40 YR Required Intervention