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

Model Number 104

Device Problems High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Neck Pain (2433)

Event Date 06/19/2018

Event Type  Injury  

Event Description

It was reported by the physician that the patient was experiencing painful stimulation in the neck where the electrodes were located.The patient's settings were subsequently turned down and the patient was referred for a full revision surgery.Diagnostics were not performed at the patient's appointment.The patient's device was subsequently disabled later in the day.It was later reported that the patient was also having erratic stimulation.No additional relevant information has been received to date.No surgical intervention has been known to have occurred to date.

Event Description

Information was received that the patient's generator was turned off.The patient's generator was tested and lead impedance was within normal limits.The physician thought that the patient's normal output was too high and not tolerable.The physician has restarted the vns therapy at the minimum dose and will gradually titrate up.

Event Description

Information was received that the patient was titrated to 0.5 ma, but couldn't tolerate stimulation as they were experiencing pain in the neck near the incision site.The patient has been referred for a full revision.No additional relevant information has been received to date.No surgical intervention is known to have occurred to date.

Event Description

Information was received that the patient is having throat pain due to an impedance issue.The patient's generator was turned off.

Event Description

Information was received that the patient did not have high impedance and device has not been interrogated since (b)(6) 2018.The patient's device was turned off due to pain no associated with stimulation and noted in the clinic notes as "per previous issues".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: 7721758
• MDR Text Key: 115069372
• Report Number: 1644487-2018-01278
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: 104
• Device Lot Number: 4114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2014
• 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): Other
• Patient Age: 51 YR