MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Extreme Exhaustion (1843); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 03/14/2021

Event Type  Injury  

Event Description

It was reported that the clinical patient experienced a dissociate state.The adverse event was reported to be probably related to vns stimulation.Vns treatment was withdrawn and psychotherapy was added.The dissociate state was reported to have resolved.It was noted the patients vns was programmed off and since the dissociative state has improved/gone away.It was noted this is a complex patient with very bad mental health status making it difficult to assess according the site.The dissociative state was reported to have begun after vns was implanted.Patient was also experiencing fatigue captured as dissociative states.Patient has hospitalized from the dissociate state and has discontinued from the trial.It was noted that the dissociate state may also be related to the migration of the generator.The dissociate state was described as disoriented, dissociating into different personalities, talking in third person.Anxiety, confusion (memory gaps) and somnolence occasionally present with the exacerbations.No additional relevant information has been received.

Event Description

Per the physician, it is not believed the patient was in a dissociate state.Physician does not believe the patient can be simply labelled in a fugue/dissociative state.The event was not believed to be related to vns per the physician as the patient was aware enough to know the device was turned off and there was a different sensation.No additional relevant information has been received.

Event Description

Overall, the picture of a dissociative stupor appeared in the foreground of the dissociative symptoms, with the patient's lack of responsiveness, sometimes lasting for days.This was so pronounced that the emergency doctor was called in more frequently.At least once there was also the suspicion of a dissociative fugue.The patient often had gaps in her memory during the period of the dissociative stupor.An independent medical expert consulted by the manufacturer had concerns on the relatedness of the dissociate state to vns.It was speculated that the single latest event would not expected to be related when all other similar events were found to be unrelated.Medical expert understands that the patient returned to "normal" after therapy was disabled; however, noted this effect would occur for a patient that is not in a dissociative state as they are aware enough to realize what is occurring and then report they are normal after the observed changes (stimulation disablement).Clinical site review of all events for the patient was performed.Retrospectively, the dissociative states have not occurred for several months after therapy was disabled; therefore, it has been assessed there is a probable connection between the dissociative symptoms and vns stimulation.No known surgery has occurred to date.No additional relevant information has been received.

Manufacturer Narrative

B5.Describe event or problem - correction - evaluation of the relationship of the study device and events observed was received.

Event Description

Xray imaging was performed of the cervical spine and compared against prior xray images.Per the site, ¿there is currently no evidence of incorrect implantation.¿ after the vns generator was programmed off, the dissociative symptoms did not occur again.This led to the most likely connection to the vagal nerve stimulation rather than the implanted device.The clinical site emphasized due to the complexity of the case, other variables could have influenced the dissociative symptoms so it could not be spoke with certainty of a reliable connection.The clinical site noted in the retrospective view, the first serious adverse event with pronounced dissociation only occurred after the start of vagal nerve stimulation (1 month after the 3 month follow up visit).These dissociative symptoms have not recurred after stimulation was programmed off.The clinic site acknowledged the addition of psychotherapy, after vagal nerve stimulation was removed, could have contributed to the elimination of dissociative symptoms.No additional relevant information has been received.

Event Description

Follow up with the clinical site reported the dissociate state had a possible relationship to vagus nerve stimulation; however, the presence of the implanted generator.No "misplacement" of the generator was detected by the site.No additional relevant information has been received.

Event Description

Subject had a full system explant as vns therapy was no longer desired.The explanted products were not available for return.No additional relevant information has been received.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12977339
• MDR Text Key: 282063291
• Report Number: 1644487-2021-01726
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/03/2023

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: 09/05/2019
• Device Model Number: 103
• Device Lot Number: 204266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 01/24/2022; 03/22/2022; 05/18/2022; 05/25/2022; 02/08/2023
• Supplement Dates FDA Received: 02/18/2022; 04/15/2022; 05/20/2022; 06/17/2022; 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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; Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Female