BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3963391 · Received July 29, 2014

    Report

    Report Number
    1644487-2014-01880
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    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

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT WAS HAVING PAIN AT HER GENERATOR INCISION SITE AND WAS UNABLE TO USE HER LEFT ARM. THE PATIENT¿S NECK INCISION SITE LOOKED GREAT, BUT THE GENERATOR INCISION SITE WAS SWOLLEN. THE PATIENT¿S PHYSICIANS STATED THAT THE SWELLING AT THE TIME WAS NORMAL. FOLLOW-UP REVEALED THAT THE PATIENT¿S NECK INCISION SCAR WAS SWOLLEN AND TENDER. THE PATIENT HAD DEVELOPED AN INFECTION AT HER INCISION SITES AND UNDERWENT SURGERY. THE DETAILS OF THE SURGERY ARE UNKNOWN. THE PATIENT WAS GIVEN HIGH DOSES OF ANTIBIOTICS AND STATED THAT SHE WAS DOING GREAT. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS EXPLANTED DUE TO THE INFECTION ON (B)(6) 2014. IT WAS REPORTED THAT THE PHYSICIAN WILL RE-IMPLANT THE PATIENT AS SOON AS SHE IS OFF HER ANTIBIOTICS AND HAS BEEN CLEARED BY INFECTIOUS DISEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR RE-IMPLANT SURGERY. THE PATIENT UNDERWENT RE-IMPLANT SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441961 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 3747

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention