MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Convulsion, Clonic (2222); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 12/07/2023

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 shortly after the patient was implanted, their device including autostim was turned on.The patient's aggravation and seizures got worse, so their device was set to the lowest output and the autostim feature was disabled.These increased seizures have now increased to above pre-vns levels.The autostim feature was recently re-enabled.Later, the patient¿s parents thought the device may have been bothering the patient with more cognitive changes, so they taped the magnet over the device.The physician has currently disabled the device while investigating a non-reportable malfunction of magnet inhibition and swipe display error on the physician's tablet to unrelated the adverse events.The impedance was reported to be within normal limits.Internal generator data was reviewed and no malfunction or anomaly was identified.No other relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr?; code 81, device evaluation and return of the device is not necessary.It will not add value to the investigation as the root cause is known.

Event Description

The physician has assessed the cause of the increase in seizures is due to external factors (not related to vns) and the levels were at or below pre-vns levels.The cause of the increased aggravation is due to external factors (not related to vns).The physician confirms the magnet was placed correctly and that the device is currently disabled.Physician states the patient had frequent seizures prior to vns implant, and does not believe it necessarily worsened anything outside of the immediate perioperative and recovery period.Device evaluation is not necessary as it will add no value to the investigation, the root cause is known.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 18842051
• MDR Text Key: 336959208
• Report Number: 1644487-2024-00258
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Model Number: 1000
• Device Lot Number: 7631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• 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): Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female