MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Inflammation (1932); Seizures (2063); Implant Pain (4561)

Event Date 03/13/2019

Event Type  Injury  

Event Description

It was reported that the patient had experienced an increase in seizure frequency, from "a few seizures here and there" to 10-12, following vns generator replacement.The patient's settings were increased due to patient not feeling stimulation, and possibly due to the patient's increase seizure frequency.The physician indicated the cause of the increased seizure frequency, despite the vns, was unknown and that the patient believed the frequency of seizures increased since the vns was turned on.No known external factors were identified that could have contributed to the increase in seizure frequency.The patient's generator did not appear to have been titrated up to therapeutic levels and the device was reportedly disabled.No further relevant information has been received to date.

Event Description

Information was received from the patient that she had increased seizures, swelling, and pain with her device at the generator site that even device disablement had not resolved.In fact device disablement made her issues worse.In the past , the pain and swelling (including neck pain and swelling) were initially reported with the generator directly after replacement.In the past, her treating physician noted that he didn't believe the pain is vns related at all and believes that it is related to her possible having cervical issues unrelated to vns in anyway, but the nurse also reported the swelling occurred directly after surgery.The current doctor noted he was referring her for explant.Diagnostics were noted to be within normal limits.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Manufacturer Narrative

B5.Describe event or problem, corrected data: supplemental mdr 1 inadvertently did not report the vns pulling at the patient's neck.

Event Description

The patient also reported she felt the vns pulling at her neck.

• Brand Name: PULSE GEN MODEL 1000
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 8553129
• MDR Text Key: 143209809
• Report Number: 1644487-2019-00790
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2020
• Device Model Number: 1000
• Device Lot Number: 204795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female