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

Model Number 106

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

Patient Problems Fatigue (1849); Cognitive Changes (2551); No Code Available (3191)

Event Date 07/11/2017

Event Type  Injury  

Event Description

Report received that a patient experienced hypersomnolence and fatigue shortly after initial vns implant.The patient was reportedly very active prior to vns, but after therapy, he became unlike himself and chose to sleep if there were no activities to do.The patient's physician also reported that the patient might have a defect in his serotonin pathway which caused the vns to affect his sleep.The patient was later seen to be in a catatonic state.The physician reportedly disabled normal mode stimulation but kept the magnet mode feature on.She speculated that the change in behavior could be due to forced normalization.Further information was received from the physician that the patient presented with delirium and rigidity while appearing catatonic.She reported that she was looking into the possibility of a neuromuscular problem related to the general anesthetic used in vns surgery.The normal mode remained off.System diagnostics were not provided and no other relevant information has been received to date.

Event Description

Further information was received that the vns was turned back on.The patient returned to the clinic and was reportedly hallucinating and presented with a slight elevation of cpk.The physician reported that this might have been due to forced normalization which was previously speculated to be contributing to the patient's earlier behavior.The device was turned back off and the patient was prescribed a low dose antipsychotic.No further information has been received to date.

Event Description

Further information was received that the patient has continued to experience psychosis issues while the vns remained off.It was reported that the patient was seizure-free with vns and remained seizure-free with the vns turned off.Because of this, the physician no longer believed the psychosis was vns-related, although it was not known what caused the psychotic issues.No further relevant information has been received to date.

Event Description

Further information was received that the physician was unable to draw a conclusion between the patient's presentation of muscle spasms and fatigue/hypersomnolence and the finding of the patient's underlying psychotic issues.The physician indicated they were likely separate events.No further relevant information has been received to date.

Event Description

Information was received the patient was being explanted at the family's request due to the behavior changes (being sedate) that he experienced while stimulation was on.Conversely, the doctor indicated that the behavior was better.Later information was received that the patient had decreased food intake at even low settings.It was reported that the high cpk levels that occurred just after vns implant and the second time the vns was turned on; however the cpk levels did not elevate when the vns was turned on a third time.It was noted that the cpk levels were suspected to be related to the anesthesia.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's generator and lead was explanted.The physician noted that the high cpk caused by neuroleptic malignant syndrome from anesthesia was ruled out.The explanted generator and lead were received for analysis, but analysis has not completed to date.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned lead.Note that a significant portion of the lead (including the electrode array) was not returned for analysis, so an evaluation and resulting commentary cannot be made on that portion of the lead.No discontinuities were identified within the returned lead portion.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The device output signal was monitored for more than 24-hrs, while the device was placed in a simulated body temperature environment.The device showed signs of variation in the output signal every 24 hours as expected at the settings programmed and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 6805431
• MDR Text Key: 83091901
• Report Number: 1644487-2017-04322
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Model Number: 106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Event Location: Other
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR