MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Cardiac Arrest (1762); Convulsion, Clonic (2222)

Event Type  malfunction  

Event Description

It was reported that patient had breakthrough seizures.Magnet swipes were attempted, but unsuccessful with aborting the seizures.Patient ultimately went into cardiac arrest and had a tracheostomy and is barely responsive.Patient is reported to have no further seizures.This patient is being considered for explant.No known relevant surgical intervention has occurred to date.No additional or 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 livanovas 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

Suspect product information has been identified.No other relevant information has been received to date.

Event Description

It was noted by the explanting facility that the device was discarded and is unavailable for return.No other relevant information has been received to date.

Event Description

It was reported that the generator was returned due to battery depletion.The device has not been returned to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 14680688
• MDR Text Key: 301026398
• Report Number: 1644487-2022-00706
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 03/12/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Model Number: 106
• Device Lot Number: 204298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 08/19/2022; 12/04/2023; 02/16/2024
• Supplement Dates FDA Received: 08/17/2022; 09/12/2022; 12/27/2023; 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• 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): Other
• Patient Age: 33 YR
• Patient Sex: Female