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 Muscle Spasm(s) (1966); Pain (1994)

Event Date 09/02/2014

Event Type  Injury  

Event Description

It was reported by a nurse that the patient had experienced discomfort.It was indicated that the patient's vns settings had been adjusted in the past but did not provide relief to the discomfort.It was reported that the patient's physician considered removing the vns.No known relevant surgical intervention has occurred to date.Multiple attempts were made to obtain additional information regarding the reported discomfort; however, no further relevant information has been received to date.

Event Description

It was reported by the patient's neurologist office that the patient experienced mild vibration and discomfort when they lay down.This occurred during stimulation on times at the generator site and the left side of the patient's neck.It was reported that this occurred since the patient's implant.No known relevant surgical intervention has occurred 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: 8897235
• MDR Text Key: 154426925
• Report Number: 1644487-2019-01576
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 10/28/2019

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: 12/23/2015
• Device Model Number: 105
• Device Lot Number: 202810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• 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): Required Intervention
• Patient Age: 29 YR