BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3854257 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01421
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAS BEEN SCHEDULED FOR REIMPLANT SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY RE-IMPLANTED VNS PATIENT UNDERWENT SURGERY ON (B)(6) 2014 TO EXPLANT HER GENERATOR DUE TO INFECTION. THE LEAD WAS NOT EXPLANTED. THE GENERATOR POCKET WAS WASHED-OUT AND CLEANED WITH ANTIBIOTICS. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332832 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202605

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention