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 Problem Muscle Spasm(s) (1966)

Event Date 08/24/2020

Event Type  Injury  

Event Description

Clinic notes were received for the patient indicating that the patient is experiencing a vibrating sensation at the generator site.The vns settings were reduced due to this.Per the physician's office, no further assessment on the cause of the vibrating sensation is available, and it is unknown if the replacement referral is related to the vibrating sensation.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient's generator was replaced prophylactically and was discarded after surgery.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10742515
• MDR Text Key: 213413833
• Report Number: 1644487-2020-01442
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

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: 01/27/2016
• Device Model Number: 105
• Device Lot Number: 202832
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 12/23/2020
• Supplement Dates FDA Received: 12/07/2020; 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR