MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Depression (2361); No Code Available (3191)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.(b)(4).

Event Description

The patient developed an infection at the generator site after generator replacement surgery.It was noted that the patient had taken two different antibiotics and the site had stopped draining.The patient was admitted to the hospital lethargic with seizures.The device was found to be working properly and settings were decreased.The patient was released from the hospital but it was noted that the patient remained lethargic and with poor appetite.It was also noted that the patient was coughing up cloudy mucus.The patient's mother believes that all of the patient's symptoms are related to the infection from the vns.Per the physician, the fatigue and loss of appetite are related to the patient's infection.No assessment was provided on the coughing up mucus.It was noted that there was no increase in seizures.When asked if the intervention was for patient comfort only or to preclude a serious injury, the physician noted that it is per the mother's request.Device history records were reviewed for the generator.The generator passed all specifications prior to distribution and was hp sterilized.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Patient problem :2544; patient problem :1908.

Event Description

Clinic notes were received from the patient's hospitalization and follow-up visit.The notes state that the patient presented to the emergency department on (b)(6) 2020 with 2-3 days of altered mental state / depressed mentation, wound issues from surgery, and change of gait.It was noted that the patient initially did well after the replacement, however recently the patient begin experiencing some nausea and vomiting.The patient then started having issues with his gait and several falls with question of presyncope.The patient was also having slight drainage from his wound from the replacement surgery but no fever or chills.Patient also had decreased energy.Ct brain was stable and the patient was admitted to the hospital to start on iv fluids and doxycycline for the cellulitis of the left chest call from the incision.Neurosurgery did not recommend any further intervention other than antibiotics.The patient's mental state and energy improved.It was noted that the suspected etiology for the patient's symptoms was slight dehydration and cellulitis.The notes state that the patient had several eegs done during hospitalization which did not show seizures.The vns was adjusted.The patient returned to the hospital on (b)(6) 2020 with hypertension, weakness, and gait ataxia.It is noted that during the last hospitalization the patient was diagnosed with toxic, metabolic encephalopathy.It is noted that this point the incision has healed nicely.It was noted that the patient is not able to bear weight and ambulate at all.The patient was vomiting again.On (b)(6) 2020 it is noted that the mom was concerned with the infection at the generator site however it does not look red and it is not tender.There were no signs of infection at this point.Information was received from the physician that the increased depression, nausea/vomiting, ambulation difficulties, and hypertension are all related to the patient's infection.The generator was explanted due to the infection.Device return/evaluation is not necessary because the reported event of infection and the associated events related to the infection are not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10167466
• MDR Text Key: 195553131
• Report Number: 1644487-2020-00816
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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: 02/04/2022
• Device Model Number: 1000
• Device Lot Number: 205205
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 28 YR