BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3900710 · Received June 27, 2014

    Report

    Report Number
    1644487-2014-01620
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    October 1, 2013
    Report Date
    May 30, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR REPORTED AN INCORRECT EVENT DATE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. AGE AT TIME OF EVENT: PREVIOUSLY SUBMITTED MDR REPORTED AN INCORRECT EVENT DATE; THEREFORE, THE PATIENT AGE IT ALSO BEING UPDATED. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR OMITTED THIS INFORMATION. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR THE GENERATOR PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT HAD ALSO BEEN SEEN IN LATE 2013 WITH A MASS ON THE CHEST INCISION. ANTIBIOTICS WERE PRESCRIBED AND THE MASS REDUCED IN SIZE GIVING THE IMPRESSION THAT IT WAS AN INFECTION. BASED ON THE SURGEON'S DESCRIPTION OF THE SURGICAL FINDINGS, IT APPEARS THAT THE CHEST POCKET WAS IN FACT INFECTED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT WAS SEEN REGARDING MIGRATION OF HER GENERATOR. IT WAS NOTED THAT THE PATIENT'S PARENTS HAVE RECENTLY NOTICED HER BATTING AT HER LEFT BREAST AREA. THE PARENTS FELT THE EDGE OF THE GENERATOR AND NOTICED THAT IT HAD SLIPPED OR MIGRATED DOWN INTO THE BREAST AND THAT THERE WAS SOME BRUISING ON THE OUTSIDE OF THE BREAST IN THE REGION OF THE GENERATOR THAT WAS QUITE PALPABLE. THE PATIENT WAS BROUGHT IN FOR EVALUATION BECAUSE OF THE MIGRATION OF THE GENERATOR WITHIN THE POCKET AND THE BRUISING OVERLYING THIS. THE NOTES INDICATE THAT UPON EVALUATION THERE WAS AN OLD YELLOWISH/REDDISH AREA LIKELY A BRUISE IN THE AREA WHERE THE GENERATOR WAS VERY SUPERFICIAL TO THE SKIN. THERE WAS NOTED TO BE SOME SKIN SLOUGHING IN THE MIDDLE OF THE BRUISE. IT WAS NOTED THAT THE PARENTS WERE NOT QUITE SURE HOW LONG THE GENERATOR HAS BEEN ITS CURRENT LOCATION. THE MOTHER REPORTED THAT WHEN THE PATIENT'S BRA IS OFF AND WHEN SHE IS GETTING READY FOR A BATH OR FOR BED SHE WILL TEND TO BAT AT HER LEFT CHEST; HOWEVER, WHEN SHE HAS HER BRA ON OR WHEN SHE IS DRESSED SHE DOES NOT SEEM TO BOTHER IT IN ANY WAY. THE MOTHER DOES NOT RECALL ANY TRAUMA TO THE AREA. IT WAS NOTED THAT THE GENERATOR HAS MIGRATED AND THAT THERE IS EVIDENCE OF BRUISING AND SKIN BREAKDOWN IN THE REGION WHERE THE GENERATOR HAS MIGRATED DOWN INTO THE LEFT BREAST LATERALLY. IT WAS NOTED THAT THE GENERATOR IS IN THE UPPER OUTER QUADRANT OF THE LEFT BREAST RATHER THAN IN THE INFRACLAVICULAR LOCATION WHERE IT WAS IMPLANTED PREVIOUSLY. IT IS POSSIBLE THAT SHE HAD SOME TRAUMA TO THE AREA, THAT THE PROLENE SUTURE SECURING THE GENERATOR INTO POSITION BROKE AND THAT SHE HAD SOME BLEEDING INTO THE POCKET. THERE IS NO EVIDENCE OF DRAINAGE OR WOUND BREAKDOWN. IT WAS NOTED THAT THE SURGEON WOULD EXPLORE THE GENERATOR SITE AND RELOCATE THE GENERATOR BACK TO A MORE DESIRABLE POSITION. OPERATIVE NOTES DATED (B)(6) 2014 WERE RECEIVED INDICATING THAT THE PATIENT UNDERWENT VNS REVISION SURGERY. THE NOTES INDICATE THAT THE GENERATOR WAS RELOCATED TO A NEW SUBCUTANEOUS POCKET SUPERIOR TO THE OLD GENERATOR POCKET. IT WAS NOTED THAT DRAINAGE OF FLUID COLLECTION WITHIN THE GENERATOR POCKET WAS PERFORMED AND SENT FOR CULTURE AND SENSITIVITY STUDIES. IRRIGATION AND DEBRIDEMENT OF THE SUBCUTANEOUS TISSUE WAS PERFORMED. IT WAS NOTED THAT AGGRESSIVE DEBRIDEMENT OF THE GENERATOR WAS PERFORMED BY PLACING IT IN MULTIPLE ANTIBIOTIC SOLUTIONS. THE EXCESS CONNECTING LEAD WAS ALSO DEBRIDED.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD AND GENERATOR WAS COMPLETED. SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. RESULTS OF DIAGNOSTIC TESTING OF THE EXPLANTED GENERATOR INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING REMOVAL OF THE VNS DEVICES DUE TO MIGRATION AND INFECTION. THE VNS GENERATOR AND LEAD WERE EXPLANTED ON (B)(6) 2015 AND THE EXPLANTED PRODUCTS WERE RECEIVED BY THE MANUFACTURER ON 1/23/2015. PRODUCT ANALYSIS IS UNDERWAY BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378301 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3033

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention