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

Model Number 103

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Convulsion, Clonic (2222); Ambulation Difficulties (2544); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 08/23/2022

Event Type  malfunction  

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 since vns implant, patient had improvement in seizure frequency and behavioral issues.However, patient has now had worsening of symptoms and a malfunction was found with their vns device.The representative reported that the malfunction they were referring to was that the device is not interrogating.The specific symptoms that are now worse for this patient is the number of seizures has increased.The last interrogation was 3 months ago.At most recent clinic visit, there was no interrogation.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The physician's assessment of the cause of increase in seizures is vns stimulation.The increase in seizures is back to pre-vns baseline.

Event Description

Physician reported that the patient's m103 was able to be palpated and was not further than an inch below the skin.The cause of the behavior change was related to vns stimulation, since when generator was not detected the behavior of the patient changed.The cause of patient falling more frequently was related to vns stimulation since when the generator was not detected the seizures increased and the patient is falling more frequently.The unspecified health problem was an increase in seizures, which is also attributed to the vns stimulation since the increase in seizures started when battery was not detected.Per the physician, the intervention of vns device replacement was for patient comfort and to preclude serious injury.The patient confirmed that they have not had any previous surgeries where this generator would have been exposed to electrical surgical tools.After generator replacement surgery, the adverse events resolved.Using the battery longevity tables, a patient programmed their settings would not be depleted yet.Therefore, if this patient's device has depleted and caused failure to program, the depletion would be premature.The suspect device has not been received into product analysis to date.No other relevant information has been received to date.

Event Description

Patient's uncle later reported that his son's vns stopped working less than a year after implant.He has behavioral issues and is violent to his family.He said they contacted an american hospital in (b)(6) and they don't know why the vns stopped working.They said they were waiting on information, and the patient got worse and started falling more and having a lot of health problems.He said the doctor told them they could replace the vns device, which they did on (b)(6) 2020 (likely 2022).No other relevant information has been received to date.

Manufacturer Narrative

F10.Corrected medical device problem code, supplemental #3 report: inadvertently added a070504 coding, but premature end of life was not alleged.

Event Description

Internal generator data was reviewed.The cause of failure to program could not be determined from the provided data.Impedance values remained within normal limits for all tests performed.The suspect device has not been received into product analysis to date.No other relevant information has been received to date.

Event Description

The generator was later received by manufacturer.Product analysis has not been completed to date.

Event Description

Product analysis for the generator was completed.The pulse generator would not interrogate.The pulse generator was opened, the measured battery voltage was confirmed to be depleted.A visual assessment on the pulse generator pcba showed contaminates on the trimmed edges of the pulse generator pcba (tab removed) due to the manufacturing process.A visual assessment on the pulse generator pcba showed contaminates on the trimmed edges of the pulse generator pcba.The contaminates observed on the trimmed edges of the pulse generator pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pulse generator pcba, which may have the contributing factor for the reported allegations of failure to program and device failure.From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion.The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion.The probable root cause is considered related to the laser-routing process (manufacturing error caused event).

• 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: 15446448
• MDR Text Key: 300146948
• Report Number: 1644487-2022-01163
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/25/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2022
• Device Model Number: 103
• Device Lot Number: 205243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 10/24/2022; 11/21/2022; 01/09/2023; 05/01/2023; 07/05/2023
• Supplement Dates FDA Received: 10/14/2022; 11/18/2022; 12/16/2022; 02/02/2023; 05/24/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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: 19 YR
• Patient Sex: Male