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

Model Number 103

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

Patient Problem Status Epilepticus (4408)

Event Date 10/09/2023

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 by the father that the patient is currently in the hospital due to status epilepticus.Father noted that the device has not been checked in years.Additional information was received noting that the patient is no longer in the hospital and will be visiting a medical professional to get an assessment battery life calculation was performed and estimations show that the device is not depleted.No other relevant information has been received to date.

Manufacturer Narrative

Gender, e1.City; corrected data; initial mdr inadvertently contained incorrect information.

Event Description

Additional information was received noting that the patient was seen in the clinic and it was found that the generator is completely depleted in battery.Patient has been referred for a battery replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

H6.Investigation conclusion; corrected data; follow-up #02 inadvertently omitted known information prior to submission.

Manufacturer Narrative

B5.Describe event; corrected information ; initial mdr inadvertently omitted information known prior to submission.D6b.If explanted, give date; corrected information ; initial mdr inadvertently omitted information known prior to submission.F10.Adverse event problem; corrected information ; initial mdr inadvertently omitted information known prior to submission.H6.Adverse event problem codes; corrected information ; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was reported that the patient was replaced due to battery depletion.The explanted device has not been received to date.No other relevant information has been received to date.

Event Description

It was later reported by the explanting facility that the device is unable to be returned (the suspect device will be assumed to be discarded).No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18056667
• MDR Text Key: 327180098
• Report Number: 1644487-2023-01579
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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,Followup,Followup,Followup
• Report Date: 04/16/2024

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 Expiration Date: 12/20/2019
• Device Model Number: 103
• Device Lot Number: 204453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 12/04/2023; 12/13/2023; 02/14/2024; 03/21/2024; 03/22/2024
• Supplement Dates FDA Received: 12/04/2023; 01/05/2024; 02/14/2024; 03/21/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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): Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male