BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX 330801

    MDR report key: 49900 · Received November 13, 1996

    Report

    Report Number
    1723248-1996-00333
    Event Type
    Injury
    Date Received
    November 13, 1996
    Date of Event
    October 9, 1996
    Report Date
    November 13, 1996
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/2115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE ANALYSIS IS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention