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 Chest Pain (1776); Edema (1820); Pain (1994); Neck Pain (2433)

Event Date 07/14/2020

Event Type  Injury  

Event Description

The patient experienced pain and swelling.The pain was noted to be in the chest where the lead connects to the generator.The pain radiates up to the left shoulder and to the vns electrode site.The pain progressed over the past 3 weeks and the symptoms were mentioned to be continuous and not related to vns on times.Diagnostics were noted to be within normal limits.The device was temporarily disabled and there was no improvement of symptoms.Despite this, the doctor indicated the pain and swelling could be related to device malfunction caused by low battery and referred the patient for implant.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Section f10.Event problem| patient code: corrected data; initial mdr inadvertently did not code that the reported pain radiates up to the electrode site and shoulder.

Event Description

The patient underwent vns explant surgery.Per hospital policy all explanted devices are destroyed.

• 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: 10456742
• MDR Text Key: 204515565
• Report Number: 1644487-2020-01132
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2013
• Device Model Number: 103
• Device Lot Number: 201984
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR