MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Seizures (2063)

Event Date 04/11/2018

Event Type  Injury  

Event Description

It was reported by the neurologist that after the patient was replaced in (b)(6) 2018 they were having seizures worse than before.When the patient was seen in office, the device had normal impedance and battery life.The patient was referred for replacement.Programming history was reviewed for the generator.No anomalies were seen.The device history record was reviewed for the generator, and it passed all specifications prior to distribution.No relevant surgical intervention has occurred to date.No other relevant information is known.

Event Description

The patient was replaced prophylactically.The explanting facility historically does not return devices.Therefore the device has not been received to date.No other additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8429193
• MDR Text Key: 139091181
• Report Number: 1644487-2019-00513
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: 11/29/2019
• Device Model Number: 104
• Device Lot Number: 5674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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): Required Intervention
• Patient Age: 36 YR