MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Muscle Spasm(s) (1966); Sleep Dysfunction (2517)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the neurologist that the patient was feeling constant vibration in their chest and neck around the vns generator and lead.It was stated that the vibration was making it difficult for the patient to sleep.It was noted that when the patient swiped the magnet the vibration would increase and turning off the device would stop the vibration.Patient was sent home with magnet taped over generator.Xrays were ordered and it was reported that no abnormalities were seen.It was noted that by the neurologist that the pain the patient was experiencing is possibly related to the muscle spasms.The patient generator was temporarily disabled by the neurologist by having the patient keep the vns magnet over the generator.It was reported by the patient's mother that the patient's seizures were getting worse with vns being disabled.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient had a generator replacement.The explanted generator has not been received to date.No corrective action is required as no new cause or new harm has been established for patient or user.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10246369
• MDR Text Key: 197982898
• Report Number: 1644487-2020-00922
• 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
• Report Date: 10/30/2020

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: 03/28/2015
• Device Model Number: 103
• Device Lot Number: 202479
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR