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

Model Number 106

Device Problems Energy Output To Patient Tissue Incorrect (1209); Under-Sensing (1661)

Patient Problems Edema (1820); Seizures (2063)

Event Date 05/27/2017

Event Type  Injury  

Event Description

It was reported on the day of replacement surgery that the patient had fluid buildup around the generator site that made the patient's treating nurse practitioner refer her for the surgery.He believed that this build-up was causing the patient to have an increase in seizures.System diagnostics were within normal limits.The generator was replaced.Follow-up from the nurse practitioner found that the replacement surgery was conducted to preclude a serious injury.He believed that the fluid pocket had been caused by an infection and had caused the increased in seizures.He suspected effusion around the generator site, and indicated that the generator could not be interrogated.He said that the patient's seizures weren't worse than they would be without the vns and indicated that infection was a possible contributory factor to the patient's increased seizures.The company representative indicated that he could interrogate the patient's generator and there was no infection on date of surgery, per the surgeon's test of the fluid around the site.He indicated that the surgeon wasn't sure of the purpose of the surgery.The patient's mother was apparently very insistent that the surgery occur.Follow up with the surgeon's office found that the fluid at the site of the generator was sterile, no bacteria or infection.The fluid was just a collection of white blood cells.They indicated that they didn't know the cause of the fluid build-up.They indicated that prior to the replacement surgery the patient had had a streptococcus infection, but that they believed she had recovered from it.The office indicated that prior to being implanted with the vns, the patient had many seizures, but after the vns was seizure free.The patient had began to have many seizures again, which was the reason for surgery, but that they didn't believe that the vns was worsening the patient's seizure rate.They said that the increased seizure rate was why the patient's surgery was to preclude a serious injury.When the patient had the increased seizure rate, the patient was admitted to the hospital and placed under a heavily medicated coma.Her magnet swipe didn't register on the tablet.The office indicated that they believed the device was shallow and easily palpable.The office also indicated that they thought that the autostimulation wasn't working.They said that they didn't believe that the vns was causing the seizures directly but that a malfunction had caused loss of therapy.They indicated that the fluid build-up was likely a coincidence and wasn't related to the seizures.Further follow-up with the patient's nurse practitioner found that the infection he had referred to prior was a streptococcus sepsis infection with toxic shock, that wasn't alleged against the vns, but that he believed could have caused the fluid buildup.He hadn't known that the fluid in the vns pocket wasn't infected.He said that he didn't know why the office had said that her infection had resolved as she was still on antibiotics for the infection at the time of the seizures.He provided the following timeline.From (b)(6)2017, the patient was hospitalized due to her infection.On (b)(6)2017, the patient went to the hospital due to the fluid build-up at the generator site.On (b)(6)2017, the patient began to have many seizures and the patient was intubated for her medications.She underwent replacement surgery on (b)(6)2017.He said that the failure to interrogate he had noted in his first follow-up was actually the failure of his tablet to pick up the magnet swipe.However, he indicated that there was a lot of fluid between the skin and the generator, which he believed increased the distance between the generator and the magnet enough that the magnet was not able to activate the generator.He said that the surgeon had been able to detect the magnet swipe on his tablet without issue after the fluid was drained, and the nurse practitioner had had no issues with detecting magnet swipes on other patients at that time.He said that he didn't believe that the autostimulation or the generator was malfunctioning, but he had thought that the fluid build-up may have caused issues with the generator and caused effusion.When asked whether he thought that the strep infection, antibiotics, or the fluid build-up had caused the increase in seizures, he said that there were so many pieces to the story it was difficult to know what had caused the increase in seizures.He said that he hypothesized that the swelling was caused by effusion from the sepsis that the patient had underwent, the explanted generator was discarded, no further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the initial mdr inadvertently omitted the following statement " it was reported that the surgeon believed that the fluid around the generator could have been from someone trying to inject fluid into the port on the patient's chest, but accidentally doing this into the generator site instead.

Event Description

It was reported that the surgeon believed that the fluid around the generator could have been from someone trying to inject fluid into the port on the patient's chest, but accidentally doing this into the generator site instead.

• 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: 6666127
• MDR Text Key: 78346213
• Report Number: 1644487-2017-04041
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2018
• Device Model Number: 106
• Device Lot Number: 203835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• 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): Required Intervention
• Patient Age: 8 YR