BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCOR

    MDR report key: 2090210 · Received May 6, 2011

    Report

    Report Number
    1723248-2011-00002
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 6, 2011
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-1771/1772/5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, RECEIVED 1" PIECE OF EXPLANTED LEAD FROM ST JUDE MEDICAL. NO INFORMATION PROVIDED. INVESTIGATIONAL LETTER SENT TO IMPLANTING PHYSICIAN. WILL CONTINUE TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCOR PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 328-752 NA

    Patients

    Seq Age Sex Outcome Treatment
    1