BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFIX

    MDR report key: 1151464 · Received September 5, 2008

    Report

    Report Number
    1723248-2008-00017
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 27, 2008
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-209/211/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENTIRE FORM FILLED OUT BY MANUFACTURER.

    Description of Event or Problem · 1

    ON 08/22/2008 RECEIVED EXPLANTED LEAD FROM ST. JUDE MEDICAL. NO INFO PROVIDED. LOCATED LEAD SERIAL NUMBER ON EXPLANTED LEAD AND USED TO SEARCH DATABASE AND IDENTIFY PATIENT. 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 NA Required Intervention