MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Hypoxia (1918); Unspecified Infection (1930); Seizures (2063); Sepsis (2067); Seroma (2069); Tachycardia (2095); Hematuria (2558)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent prophylactic generator replacement surgery.Diagnostic testing at the surgery showed that the generator was functioning properly.It was then programmed on following the surgery.A week later, the patient was experiencing an increase in seizures after missing doses of antiepileptic drugs for several days.She presented to the hospital in a status epilepticus state with symptoms that suggested the patient was suffering from meningitis and/or sepsis.Lab results showed the patient had elevated levels of white blood cells which led to concerns of a possible infection.The generator incision site was evaluated and it was noted that there were no sign of an active infection as the wound was dry and healing well.There was no erythema or purulence observed around the generator.The neurosurgery department did not suspect that the symptoms of sepsis were related to the recent generator replacement surgery.However due to the timing of events, the surgery was not ruled out as a possible contributing factor at the time.Manufacturing records showed that the generator was sterilized prior to distribution.The patient was then admitted to the intensive care unit where she was intubated, an eg tube was placed and a picc line was placed to deliver a course of antibiotics.While admitted the antibiotics were continued for 7 days and the antiepileptic drugs were titrated.During her admittance, she reportedly suffered from intermittent tachycardia.She also suffered from acute hypoxemic respiratory failure which was believed to be associated with her seizures and the sedation from the antiepileptic drugs.The patient also experienced hematuria which was caused by the placement of a foley catheter.After a few days in the icu, the patient was extubated.A couple of days later, an ultrasound found a small amount of fluid around the generator which appeared to be a seroma.After a week of being admitted the hospital, it was decided that the patient's clinical presentation was more consistent with status epilepticus than an infection.Therefore, the picc line was removed and antibiotics were discontinued.The patient was discharged the following day where she was noted to be medically stable and her white blood cell had returned to normal.She was instructed to continue her antiepileptic drugs and to monitor her heart rate and the fluid collection at the generator site.No additional relevant information has been received to date.

Event Description

It was reported that two days prior to presenting to the hospital in a status epilepticus state the patient had 2 grand mal seizures.Then 24 hours later she had another 2 grand male seizures.The following day she went into a status epilepticus state.Her caregiver attempted to give her a dose of midazolam however it did not stop the seizures.The patient then missed doses antiepileptic medication due to the frequency of the seizures.At a follow-up appointment since being released from the hospital it was noted that the patient was mentally and physically stable.The physician did not know the cause of the status epilepticus event however it was noted that the patient had missed a dose of antiepileptic medication.During the visit it was noted that the vns was functioning.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6064124
• MDR Text Key: 58657986
• Report Number: 1644487-2016-02511
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 203780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR