BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 1151447 · Received September 5, 2008

    Report

    Report Number
    1723248-2008-00022
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 28, 2008
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2080, REC'D EXPLANTED LEAD FROM ST. JUDE MEDICAL. NO INFO PROVIDED. LOCATED LEAD SERIAL NUMBER ON EXPLANTED LEAD AND USED TO SEARCH DATABASE AND IDENTIFY PT. INVESTIGATIONAL LETTER SENT TO PHYSICIAN AND CENTER IN PT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 330-801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization