MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number	102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Extreme Exhaustion (1843); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that patient has been having trouble with her device for the past six months.Patient has had muscle spasms from her head to the bottom of her abdomen, and shocking down the left side of her chest.Patient notes that ever since she has had the device, it has been painful yet tolerable once her settings were managed.Over the past 6 months the muscle spasms and shocking are constant, but the stimulation makes them symptoms worse.The pain is so bad it makes her grunt.Patient is also experiencing fatigue.Psychiatrist lowered settings but that has not helped with any symptoms.Patient further reports she had a chest x-ray and and ct due to the pain.Additional information was received that patient improved on discontinuation of vns stimulation but still experiences abdominal and some chest muscle spasms.Patient also reports spasm or shocks and responses also happen with increased anxiety.The physician may adjust anxiety medicine and or taper off her risperidore.They were able to discontinue output current successfully and patient reacted well.No other relevant information has been received to date.
Event or Problem Description
It was reported that the patient is scheduled for explant.This is indicative of intervention taken.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
The patient reports that the abdominal spasms continued despite the vns being explanted.It was previously reported muscle spasms were exacerbated by vns stimulation, rather than being a casual factor.This report has yet to be confirmed by an hcp; therefore no conclusions will be updated the explanted device has not been received to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Common Device Name: 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: 15655335
• Report Number: 1644487-2022-01317
• Device Sequence Number: 2455057
• Product Code: MUZ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2016
• Device Model Number: 102
• Device Lot Number: 203036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 05/30/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 02/08/2023; 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female