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 Problems Convulsion, Clonic (2222); Status Epilepticus (4408)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that the patient was sent to the emergency room due to seizures.The patient experienced a seizure in school.The patient¿s last tonic clonic seizure was in 2016.This seizure will be classified as an increase, as this patient has not experienced this seizure type for quite some time.No other relevant information has been received to date.

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.

Manufacturer Narrative

B2.Outcomes attributed to adverse events, f10.Health effect - clinical code; corrected data; initial mdr inadvertently reported incorrect data.F10.Health effect - impact code; corrected data; initial mdr inadvertently listed; hospitalization.

Event Description

Clinic notes were received containing device setting and diagnostics and that emergency medication was used to try and stop seizure.No other relevant information has been received to date.

Event Description

It was reported that the suspect product has been replaced due to battery depletion.The explanted device has not been received to date.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: 18260535
• MDR Text Key: 329638720
• Report Number: 1644487-2023-01711
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2024

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: 07/28/2016
• Device Model Number: 103
• Device Lot Number: 3993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 01/29/2024; 02/20/2024
• Supplement Dates FDA Received: 12/21/2023; 02/21/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• 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; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male