MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Undesired Nerve Stimulation (1980); Neck Pain (2433); Sleep Dysfunction (2517)

Event Date 09/07/2018

Event Type  Injury  

Event Description

It was reported that the patient was feeling painful, erratic stimulation throughout the left side of her neck where the lead is located.The lead was previously not visible, but was reported to now be protruding against the patient's neck.It was reported that the patient had lost some weight.Lead impedance was reported to be normal with multiple diagnostics being performed.It was also stated that the patient was unable to sleep due to the stimulation.It was reported that the physician had ordered x-rays; however, these have not been reviewed by the manufacturer to date.The patient's device was later disabled, and the patient was referred to a surgeon for surgery.The neurologist reported that the erratic stimulation was believed to be related to a possibly disconnected lead, and that the cause of the protrusion was not known.The neurologist indicated that the surgical consult was not due to or to preclude a serious injury.No known surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 7949664
• MDR Text Key: 123192089
• Report Number: 1644487-2018-01798
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2015
• Device Model Number: 105
• Device Lot Number: 3682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR