BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2761220 · Received September 26, 2012

    Report

    Report Number
    1644487-2012-02444
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    April 30, 2012
    Report Date
    August 28, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE EXPLANT DATE, CORRECTED DATA: THE PREVIOUS REPORT DID NOT REPORT THE DATE OF EXPLANT.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: WITH THE ADDITIONAL INFORMATION RECEIVED, THE INITIAL REPORT INADVERTENTLY REPORTED THE DATE INCORRECTLY, AND THEREFORE, THE PATIENT'S AGE AT THE TIME OF THE EVENT WAS INCORRECT. DATE OF EVENT, CORRECTED DATA: WITH THE ADDITIONAL INFORMATION RECEIVED, THE INITIAL REPORT INADVERTENTLY REPORTED THE DATE INCORRECTLY.

    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

    THE PATIENT'S CAREGIVER REPORTED THAT IN FOLLOW-UP WITH THE NEUROSURGEON ON (B)(6) 2012, THE STITCHES WERE REMOVED FROM THE NECK AREA TO ALLOW FOR DRAINAGE. THE PATIENT IS ON KEFLEX. THE PATIENT WAS READMITTED ON (B)(6) 2012, WHERE INCISION AND DRAINAGE WAS PERFORMED ON THE NECK ABSCESS. HE IS BEING TREATED WITH ANTIBIOTICS, AND MOST LIKELY WILL HAVE TO REMAIN ON THOSE. THE SURGEON REPORTED TO THE PATIENT'S FAMILY THAT HE DOES NOT THINK THE PATENT WOULD BE A GOOD CANDIDATE FOR RE-IMPLANT OF VNS. ATTEMPTS FOR ADDITIONAL INFORMATION ON THE PATIENT'S STATUS HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT WAS EVALUATED BY THE SURGEON'S OFFICE ON (B)(6) 2013, AND THE SURGEON'S OFFICE REPORTED THAT THEY RELEASED THE PATIENT FROM FURTHER CARE STATING THAT THE INCISION IS HEALED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012, INDICATED THAT THE PATIENT HAD AN AREA OF ERYTHEMA AND "THERE IS PACKING IN THE WOUND". "HIS VNS SITE IS MILD ERYTHEMATOUS AND IS PACKED, BUT NO DRAINAGE".¿ IT ALSO INDICATED THAT THERE WAS PURULENT DRAINAGE FROM THE VNS UNIT. INTERROGATION OF THE GENERATOR REPORTEDLY SHOWED THAT IT WAS "DOING WELL". IN NOTES DATED (B)(6) 2012 AFTER GENERATOR REPLACEMENT, IT WAS REPORTED THAT THE PATIENT WAS DOING WELL UNTIL HE DEVELOPED SOME SWELLING AND BLEEDING OVER THE GENERATOR SITE. THE SKIN WAS INFLAMED. THE PHYSICIAN INDICATED THAT THE PATIENT DOES HAVE SELF ABUSIVE BEHAVIORS AND IS FELT TO HAVE PICKED AT THE WOUND. EVEN THOUGH IT HAD INITIALLY HEALED UNEVENTFULLY, CULTURES SHOWED STAPHYLOCOCCAL INFECTION. THE PATIENT WAS PUT ON ANTIBIOTICS. THE PATIENT HAS BEEN REFERRED FOR VNS REIMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON INDICATING THAT THE INFECTION WAS FIRST OBSERVED ON (B)(6) 2012. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND PACKING. AS OF (B)(6) 2012 WITH THE INFORMATION WAS RECEIVED, THE WOUND WAS HEALING. THE SURGEON REPORTED THAT THE INFECTION WAS BELIEVED TO BE RELATED TO THE VNS SURGICAL WOUND. THE INDIVIDUAL IS SEVERELY BRAIN INJURED, AND THE SURGEON SUSPECTS THAT HE PICKED AT THE HEALING WOUND. CULTURES WERE TAKEN, AND THE RESULTS CONFIRMED THE INFECTION AS STAPHYLOCOCCUS AUREUS. LATER, OPERATIVE NOTES WERE RECEIVED FROM THE SURGEON'S OFFICE REPORTING THE DESCRIPTION OF OPERATION FOR THE REMOVAL OF THE GENERATOR AND LEAD ON (B)(6) 2012. THE PRE- AND POST-OPERATIVE DIAGNOSES CONFIRMED "INFECTED VNS GENERATOR". AFTER GENERATOR PLACEMENT, IT WAS REPORTED THAT THE WOUND HAS DEHISCED AND DRAINED. THE PATIENT WAS THEREFORE RECOMMENDED FOR REMOVAL OF THE VNS DEVICES. AFTER REMOVING BOTH THE GENERATOR AND LEAD, THE WOUND WAS COMPLETELY DEBRIDED. THROUGH IRRIGATION WITH ANTIBIOTIC SOLUTION AND PEROXIDE WAS PERFORMED. THE PATIENT WAS TAKEN TO RECOVERY AFTER SURGERY WITH STABLE VITAL SIGNS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON'S OFFICE REPORTED THAT THE PATIENT'S SISTER INDICATED THAT THE INCISION LOOKS GOOD. SHE THINKS IT HAS HEALED WELL, AND SURGEON'S OFFICE NOTED THAT THE SISTER IS USUALLY THE ALARMIST. THE PATIENT HAS ALSO BEEN FOLLOWED WEEKLY BY HOME HEALTH CARE SERVICES.

    Description of Event or Problem · 1

    THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT IS DOING WELL SINCE HAVING THE DEVICE EXPLANTED, AND THE TREATING PHYSICIAN INDICATED NO NEED TO IMPLANT VNS AGAIN UNLESS SEIZURES RETURN. NO REPLACEMENT IS PLANNED AT THIS TIME DUE TO THE PATIENT'S GOOD SEIZURE CONTROL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON'S OFFICE ON (B)(4) 2012. THE INFECTION HAS NOT RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A CHRONIC INFECTION IN THE GENERATOR POCKET, PER THE PATIENT'S SURGEON. THE SURGEON WANTED TO EXPLANT THE DEVICE, CLEAN THE POCKET AND RE-IMPLANT A DEVICE ON THE SAME DAY. THE PATIENT HAD SURGERY ON (B)(6) 2012 PER THE SURGEON'S OFFICE. THE SURGEON IRRIGATED THE GENERATOR POCKET AREA AND IS WAITING ON THE CULTURES TO COME BACK. A REPLACEMENT DEVICE WAS NOT RE-IMPLANTED. THE PATIENT WAS STILL IN THE HOSPITAL ON (B)(6) 2012 AND CONSULTED WITH THE INFECTIOUS DISEASE PHYSICIAN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2762

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention