BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX 330801

    MDR report key: 60859 · Received December 31, 1996

    Report

    Report Number
    1723248-1996-00449
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    September 18, 1996
    Report Date
    December 23, 1996
    Manufacturer
    TELETRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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

    DEVICE ANALYSIS IS PROVIDED. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR. TECHNIQUE/TOOLS: INTRAVASCULAR COUNTER TRACTION, SHEATH(S). NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX 330801 Implant CARDIOVASCULAR PERMANENT PACING ELECTRODES DTB TELETRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention