BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFIX

    MDR report key: 71391 · Received February 19, 1997

    Report

    Report Number
    1723248-1997-00115
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    February 10, 1997
    Report Date
    February 18, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z209/211-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION UNDER 30X MAGNIFICATION INDICATES NO J STIFFENER WIRE DISCREPANCIES. X-RAY OF LEAD 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 Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other