MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number	102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Seizures (2063); Anxiety (2328); Neck Pain (2433)
Date of Event	05/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient started experiencing pain at the generator site recently.The pain was not reported to be associated with stimulation.The pain is however causing the patient to have panic attacks which lead to increased seizures.Patient was provided a neurologist contact information and asked to follow up with the physician regarding the concerns.However, no additional relevant information was received.
Event or Problem Description
Additional information was received that the patient is still having pain in his arms/legs and generator site, but this pain is present even when the device is "off." patient has held the magnet up to his generator for 5 minutes at a time t temporarily disable stimulation, and experiences worse pain during the disablement.The pain often wakes him from sleep and he wakes up in a sweat.Patient said that a doctor has mentioned that this could be related to anxiety, but it has not been confirmed.Additional information was received that the patient's vns settings were programmed at unusual setting of 30 seconds on time and 150 minute off time.The reason patient was feeling pain during the stimulation was because the settings were too high and there was a long break in between.The physician adjusted the patient's settings to a normal duty cycle and reduced the output current but the settings and diagnostics were not provided.Seizure patterns will be evaluated on an ongoing basis now that the vns has been programmed appropriately.
Event or Problem Description
Patient underwent explant surgery due to shoulder and neck pain.The physician stated that the patient demanded it be removed due to shoulder and neck pain.A portion of the lead was cut but the electrodes remain implanted.No other relevant information was received.
Event or Problem Description
Follow-up was later received that the patient will have the remaining portion of the lead removed.The additional surgery is not known to have occurred to-date.
Event or Problem Description
The additional surgery to remove the remaining portion of the lead occurred.

• Brand Name: PULSE GEN MODEL 102
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 5704559
• Report Number: 1644487-2016-01281
• Device Sequence Number: 715339
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 102
• Device Lot Number: 3676
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/10/2018; 08/09/2018
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 07/22/2016; 01/23/2017; 07/16/2018; 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR