BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2942451 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00284
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN STATING THAT THE WOUND WAS BETWEEN THE NECK AND THE CHEST, AND THAT THE PATIENT WENT TO THE DOCTOR INITIALLY TO CHECK ON THE VNS BUT A WOUND UNDER A CREASE WAS NOTICED. IT WAS STATED THAT THEY WERE ABLE TO VISUALLY SEE THE LEAD. AFTER EXPLANTING THE LEAD THEY WOULD IMPLANT ANOTHER LEAD AFTER THE WOUND HEALS. ATTEMPTS TO FIND OUT MORE DETAILS ABOUT THE SURGERY WERE UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING THE VNS LEAD AND GENERATOR EXPLANTED DUE TO THE PATIENT PICKING AT THE LEAD SITE. THE LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013. ACCORDING TO THE PHYSICIAN NO INFECTION WAS NOTED, BUT THE LEAD WAS EXTRUDED. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WHERE HE WAS RE-IMPLANTED WITH AN M102 VNS GENERATOR AND M304-20 VNS LEAD. AN IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE PATIENT'S LEAD IMPEDANCE OF THE IMPLANTED GENERATOR AND LEAD WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46747 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202121

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R