MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Muscle Spasm(s) (1966); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing discomfort from the presence of the vns device, and would like to have the device repositioned more superficial and medial.Prior to surgery, the patient also reported neck mobility issues, and it was noted that the generator repositioning surgery was also to address this issue.The patient underwent generator repositioning surgery.The diagnostics were noted to be within normal limits.After the surgery, both the discomfort and neck mobility issues resolved.No additional relevant information has been received to date.

Event Description

Per the surgeon, the cause of the pain and neck mobility issues was due to the presence of the vns, specifically where the generator was placed.No additional relevant information has been received to date.

Event Description

Information was received that at the most recent follow up appointment, the vns system diagnostics were within normal limits.No additional relevant information has been received to date.

Event Description

It was reported that the patient would like the vns explanted due to the adverse events persisting.The patient reported dyspnea and itchiness/allergic reactions at the generator site, as well as persistent discomfort when shooting her rifle or when at the gym.The explant surgery is for patient comfort.No further relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿allergic reaction¿ is not available.

Event Description

The patient underwent vns explant due to persisting pain.The explant facility is known not to return any explants.Additional relevant information has not been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10843831
• MDR Text Key: 216360794
• Report Number: 1644487-2020-01538
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/10/2021

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: 12/16/2021
• Device Model Number: 1000
• Device Lot Number: 205293
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 01/26/2021; 03/17/2021; 04/15/2021
• Supplement Dates FDA Received: 12/22/2020; 02/04/2021; 04/09/2021; 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR