MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number	104
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient's vns could not be interrogated.The physician has recommended a replacement and the patient believes her device may have depleted prematurely.No other relevant information has been received to date.No known surgical intervention has occurred to date.
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.
Additional Manufacturer Narrative
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.).
Event or Problem Description
Additional information was received from the physician that the patient was also experiencing increased depression.The patient was provided additional medication in response to the increased depression and was referred for a battery replacement.Additional information was received that the patient underwent a full system revision.It was determined that the generator had migrated following the patient having breast implant procedure.Per the physician, the cause of the migration was due to the breast implant procedure.Upon interrogating the device, high impedance and low output current were seen, therefore a full system revision was performed.The explanted devices were taken to pathology and have not been returned to livanova to date.Per the physician, the patient's increased depression was caused by the device not functioning properly (high impedance).The patient's depression was noted to be above pre-vns baseline levels the reported high impedance and increased depression will be captured in report 1644487-2025-00127.No other relevant information has been received to date.
Additional Manufacturer Narrative
B1 adverse event or product problem, corrected data: supplemental #1 inadvertently did not select "adverse event" b2 outcomes attributed to adverse event, corrected data: supplemental #1 inadvertently did not select "required intervention to prevent permanent damage/impairment".

• Brand Name: PULSE GEN MODEL 104
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 21124109
• Report Number: 1644487-2025-00023
• Device Sequence Number: 21022740
• Product Code: MUZ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 03/07/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/05/2022
• Device Model Number: 104
• Device Lot Number: 205254
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/07/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female