BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2961370 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00402
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    ANALYSIS OF THE GENERATOR WAS COMPLETED. NO ANOMALIES WERE NOTED AND THE GENERATOR PERFORMED PER SPECIFICATIONS. ALL ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE REPORTER ABOUT THE INFECTION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED THE INFECTION WAS AT THE GENERATOR SITE, AND THE CAUSE OF THE INFECTION IS UNKNOWN. THE INFECTION STARTED AS A "BUBBLY RASH". CULTURES WERE DONE WHICH GREW OUT (B)(6). THE PATIENT HAD NO TRAUMA AND DID NOT MANIPULATE THE VNS. THE PATIENT RECEIVED LEVAQUIN ANTIBIOTICS AND IS RECOVERING WELL FROM THE INFECTION.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD THE VNS LEAD AND GENERATOR EXPLANTED ON (B)(6) 2013 DUE TO INFECTION. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED. ANALYSIS OF THE LEAD DID NOT IDENTIFY ANY ANOMALIES OTHER THAN TYPICAL EXPLANT-RELATED OBSERVATIONS. ANALYSIS OF THE GENERATOR IS PENDING. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65673 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 3402

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention