BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 103381 · Received July 2, 1997

    Report

    Report Number
    1723248-1997-00515
    Event Type
    Injury
    Date Received
    July 2, 1997
    Date of Event
    December 18, 1996
    Report Date
    July 1, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z2095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO J WIRE FRACTURES. X-RAY OF LEAD CONFIRMS NO J STIFFENER WIRE FRACTURES.

    Description of Event or Problem · 1

    EXPLANT METHODS: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION WITH LOCKING STYLET, 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 61 YR Other| R