BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4925791 · Received July 20, 2015

    Report

    Report Number
    1644487-2015-05251
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE SURGEON INDICATES THAT THE CAUSE OF THE GENERATOR MIGRATION IS UNKNOWN BUT MAY HAVE BEEN RELATED TO THE SUBSTANCE HE OBSERVED AROUND THE GENERATOR, WHICH HE BELIEVED TO BE INFECTED TISSUE, WHEN HE OPENED THE POCKET. THE SURGEON STATED THERE WAS NO MANIPULATION OR TRAUMA THAT HE WAS AWARE OF AND THE PATIENT DID NOT APPEAR TO BE A TWIDDLER. HE STATED THAT NON-ABSORBABLE SUTURES WERE USED TO SECURE THE GENERATOR DURING ITS IMPLANT. HE STATED THE PLANNED INTERVENTION TO REPOSITION THE DEVICE WAS FOR PATIENT COMFORT BUT THE INTRA-OPERATIVE REMOVAL WAS DEEMED APPROPRIATE GIVEN THE FINDING OF WHAT HE THOUGHT TO BE SIGNS OF AN INFECTION. THE GENERATOR AND ALL BUT ONE INCH OF THE ELECTRODE PORTION OF THE LEAD WERE EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WOULD HAVE HIS DEVICE REPOSITIONED TO ADDRESS PAIN CAUSED BY GENERATOR MIGRATION. CLINIC NOTES OBTAINED INDICATED THAT THE PATIENT¿S TREATING NEUROLOGIST NOTED PAIN AND TENDERNESS AT THE VNS SITE AND STATED THAT THE GENERATOR HAD MIGRATED TOWARDS THE STERNUM. THE PATIENT¿S VNS SYSTEM WAS TESTED AND SHOWED NORMAL DEVICE FUNCTION. THE PATIENT¿S SURGEON DESCRIBED THAT THE GENERATOR HAD SHIFTED MEDIALLY ON HIS CHEST AND OVERLIES THE COSTOSTERNAL BORDER, IT WAS UNCOMFORTABLE WITH NO REDNESS, SWELLING, INFLAMMATION, OPEN WOUNDS, OR DRAINAGE AND THAT THE PATIENT¿S PAIN WAS EXACERBATED BY PUSHING ON THAT AREA. IT WAS SUBSEQUENTLY REPORTED THAT DURING THE REPOSITIONING SURGERY THE SURGEON EXPLANTED THE GENERATOR AND THE LEAD (ELECTRODES REMAINING) DUE TO INFECTION. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE REPORTED INFECTION IS REPORTED IN MFR. REPORT #: 1644487-2015-05254.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469680 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2773

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention