BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4565524 · Received March 3, 2015

    Report

    Report Number
    1644487-2015-04021
    Event Type
    Injury
    Date Received
    March 3, 2015
    Date of Event
    November 1, 2014
    Report Date
    February 11, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING SURGERY TO REPOSITION THE VNS GENERATOR AS IT IS EXTRUDING FROM THE SKIN. THERE WAS NO PATIENT MANIPULATION THAT LED TO THE EXTRUSION. THE IMPLANTING SURGEON DID NOT USE AN ABSORBABLE SUTURE FOR THE PLACEMENT OF THE GENERATOR AND THERE WERE NO KNOWN TRAUMA OR OBVIOUS CAUSE FOR THE EXTRUSION OF THE DEVICE. THE PATIENT WAS SEEN BY THE NEUROLOGIST¿S OFFICE IN (B)(6) 2014 WHEN PATIENT HAD INITIALLY REPORTED THE EXTRUSION BUT THE NEUROLOGIST OFFICE COULD NOT IDENTIFY THE CAUSE OF DEVICE EXTRUSION. THE PATIENT UNDERWENT REPOSITIONING SURGERY ON (B)(6) 2015. FOLLOWING SURGERY, THE PATIENT EXPERIENCED SWELLING, PAIN AND REDNESS IN THE CHEST. THE PATIENT WAS PRESCRIBED ANTIBIOTICS PROPHYLACTICALLY TO PREVENT AN INFECTION. IT WAS LATER REPORTED THAT THE PATIENT HAD FLUID COMING FROM THE GENERATOR SITE IN THE CHEST. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON 02/20/20115 FOR THE INFECTION AND WAS ADMINISTERED WITH ANTIBIOTICS INTRAVENOUSLY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE SURGEON ON (B)(6) 2015. ACCORDING TO THE PATIENT THE SWELLING, REDNESS, AND FLUID ACCUMULATION STARTED AROUND (B)(6) 2014 AFTER ROUTINE GENERATOR REPLACEMENT THE MONTH BEFORE. THE EVENTS ARE RELATED TO THE PRESENCE OF THE DEVICE. INTERVENTIONS WERE TAKEN BOTH FOR PATIENT COMFORT AND TO PRECLUDE A SERIOUS INJURY. ADDITIONAL INTERVENTIONS INCLUDED WOUND IRRIGATION AND LOCAL STEROID INJECTIONS. THE INTERVENTIONS WERE OF MINIMAL HELP. THE SURGEON BELIEVES THE PATIENT HAS DEVELOPED A TITANIUM ALLERGY OR HYPERSENSITIVITY AND THAT THE ONLY RECOURSE IS TO TOTALLY REMOVE THE GENERATOR AND LEAD. ALL CULTURES FOR INFECTION HAVE BEEN NEGATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2015 FOR THE PREVIOUSLY REPORTED INFECTION. THE EXPLANTED PRODUCT WAS NOT RETURNED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146364 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3890

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R