BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3882083 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01529
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DEVICE HISTORY RECORDS WERE REVIEWED. REVIEW OF THE GENERATOR DEVICE HISTORY RECORDS CONFIRMED STERILIZATION WAS PERFORMED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT MAY HAVE EXPERIENCED SOME SORT OF AN AXILLARY INFECTION IN (B)(6) 2014 FROM POKING AND SCRATCHING AT HIS DEVICE. THE PATIENT¿S DEVICE WAS REPORTED TO BE FUNCTIONING WELL AT THE TIME. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 REPORTED THAT THE PATIENT HAD BEEN TREATED FOR AN ¿ABSCESS¿ IN THE LEFT AXILLAE WITH AN INCISION AND DRAINAGE BY HIS PRIMARY CARE PHYSICIAN ON TWO OCCASIONS RECENTLY. THE MOST RECENT WAS ABOUT A WEEK AND A HALF PRIOR. THE PATIENT DENIED ANY ANTIBIOTIC PRESCRIPTION GIVEN. THE PATIENT REPORTED THAT IT HAD RETURNED SOMEWHAT. UPON PHYSICAL EXAMINATION, THERE WAS AN APPROXIMATE 1.5 INCH LENGTH PALPABLE LESION IN THE LEFT AXILLAE WHICH WAS SOFT BUT NOT MOBILE. THERE WAS NO REDNESS OR SKIN BREAKDOWN. THERE WAS NO TENDERNESS TO PALPITATION. THE PHYSICIAN¿S ASSESSMENT AT THAT TIME WAS THAT THE LESION MAY REPRESENT A STERILE CYST VERSUS INFECTION ABSCESS WITH THE INFECTION ABSCESS LESS LIKELY. CLINIC NOTES DATED (B)(6) 2014 REPORTED THAT THE PATIENT HAD AN AXILLARY CYST WHICH HAD SINCE BEEN DRAINED AND APPEARED TO HAVE IMPROVED AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358726 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 3492

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R