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 Diarrhea (1811); Nausea (1970); Tachycardia (2095); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that the patient is experiencing tachycardia and currently has their autostim turned off.No other relevant information has been received to date.

Event Description

Update was received that the patient had their vns disabled due to discomfort with the device.The surgeon proposed removing the vns to relieve their symptoms, however the patient does not want to pursue an explant.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event.Corrected information; follow-up report #2 inadvertently omitted information known prior to submission.D6b.If explanted, give date.Corrected information; follow-up report #2 inadvertently omitted information known prior to submission.F10.Adverse event problem: health effect - impact code.Corrected information; follow-up report #2 inadvertently omitted information known prior to submission.H6.Adverse event problem codes: type of investigation.Corrected information; follow-up report #2 inadvertently omitted information known prior to submission.

Event Description

Implant card was received reporting a full revision.The suspect device has not been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿voice alteration¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event ).Health effect - clinical code :e0112, health effect - clinical code :e0116, health effect - clinical code :e2109, health effect - clinical code :e1605, health effect - clinical code :e2402.

Event Description

X-rays were provided for review.It was noted that the patient experiences head nodding with stimulation and that the generator moves within the patient's pocket.Clinic notes were received reporting that the patient is being referred for surgery.The notes also reported that the patient is experiencing voice alteration, chest pain, muscle spasms (titubation), headache, dizziness, nausea, diarrhea, and dyspepsia.

• Brand Name: PULSE GEN MODEL 106
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17887733
• MDR Text Key: 325126965
• Report Number: 1644487-2023-01437
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 7498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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): Other
• Patient Age: 39 YR
• Patient Sex: Female