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 05/13/2019

Event Type  Injury  

Event Description

A report was received that the patient was admitted into the er due to an increase in seizures.It was stated that the physician had called the representative to confirm the device settings were correct after the patient's generator replacement surgery.An implant form was received indicated the patient's system diagnostics were within normal limits at the time of the replacement.Further information was received stating that the on call provider was the one who informed the representative that the patient was in the hospital for more seizures, and wanted to ensure patients device was turned back on after surgery, and representative confirmed it was.No additional relevant information has been received to date.

Event Description

Information was received that the patient's managing physician did not believe the increase in seizures is related to the vns but rather the patient not tolerating their medication post-operatively (after the vns implantation surgery).The physician did not say whether the seizures were worse than pre-vns baseline.It was reported that there were no other factors contributing to the increase in seizure frequency.No additional 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: 8678268
• MDR Text Key: 147311757
• Report Number: 1644487-2019-01085
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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: 12/18/2020
• Device Model Number: 104
• Device Lot Number: 202791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: 52 YR