BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6274136 · Received January 24, 2017

    Report

    Report Number
    1644487-2017-03072
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    December 16, 2016
    Report Date
    November 10, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAD DRAINAGE AT THE CHEST INCISION SITE AFTER SURGERY ON (B)(6) 2016. THE PATIENT WAS TREATED WITH ANTIBIOTICS. FOLLOW-UP WITH THE COMPANY REPRESENTATIVE PROVIDED THAT THE DRAINAGE HAD CLEARED UP AFTER ADMINISTRATION OF ANTIBIOTICS. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THE GENERATOR AND LEAD HAD BEEN STERILIZED PRIOR TO DISTRIBUTION. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE PROVIDER INDICATED THE GENERATOR HAD BEEN EXPLANTED, AND THE LEAD WAS LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57236 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 4851

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention