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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

Patient Problems Convulsion, Clonic (2222); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

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 during a dosing appointment for patient that when trying to run a diagnostics they also kept getting an error code 254 and 128.The patient also had low output current.Later, it was also confirmed patient had a low impedance.It was later reported that the patient was not displaying any symptoms of loss of vns therapy.There was no generator reset performed.Since error code 254 was seen with low output current and low impedance after diagnostics, a reed switch malfunction is the most probably cause to date.As we receive more information we will continue to evaluate.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.Internal investigation into similar events was unable to determine a definitive root cause of reed switch failures.The primary root cause is believed to be reed switches sticking in the closed position after extended exposure to magnetic fields.The investigation also identified residual magnetic properties of the generator battery to be a potential contributor; however, testing performed during the investigation found the effect to be highly variable with each magnetic field exposure and any closure of the reed switch impacted by this phenomenon would likely be reversed by subsequent swiping of the patient magnet.Thus, the most likely contributor of the identified complaints is considered to be mechanical sticking of the reed switch blades.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Corrected description of event, initial report: inadvertently left out information regarding the increase in seizures.F10.Corrected clinical code, initial report: inadvertently left out additional e010901 coding for seizures.F10.Corrected impact code, initial report: inadvertently left out additional f0101 coding for therapeutic response decreased.

Event Description

Physician later reported that the patient was experiencing an increase in seizures.The low impedance did not occur after attempting a generator reset.No other relevant information has been received to date.

Event Description

Troubleshooting attempts such as rapid magnet swipes and a generator reset were performed to try to ¿unstick¿ the reed switch.However, this was unsuccessful.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Internal generator data was received and reviewed.The data was consistent with that of a stuck reed switch malfunction.No known relevant surgical intervention has occurred to date.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16075673
• MDR Text Key: 306619560
• Report Number: 1644487-2022-01686
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 03/23/2023

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: 05/04/2024
• Device Model Number: 1000
• Device Lot Number: 205816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/24/2023; 02/17/2023; 03/07/2023
• Supplement Dates FDA Received: 01/24/2023; 03/02/2023; 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 33 YR
• Patient Sex: Female