MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Hiccups (1899); Depression (2361); Neck Pain (2433)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Patient reported pain in their neck at lead site when turning his head and bending down and also onset of chronic hiccups.There were no reports of fall or injury.A chest and neck x-ray were ordered and referral for a possible lead revision was noted.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information received reporting that the discomfort with stimulation has caused the patient to feel depressed.

Manufacturer Narrative

B1.Adverse event or product problem , corrected data: initial report inadvertently did not mark product problem b2.Outcomes attributed to adverse event, corrected data: initial report inadvertently left blank b5.Describe event or problem , corrected data: initial report inadvertently left out details about the events reported.F10.Adverse event problem, corrected data: initial report inadvertently did not code 'e020202' and 'f0101' h1.Type of reportable event , corrected data: initial report inadvertently marked serious injury instead of malfunction.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.After the replacement the patient was still experiencing hiccups and they have gotten worse.Once the patient taped the magnet over the device this resolved the issue.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12263185
• MDR Text Key: 264712660
• Report Number: 1644487-2021-01047
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 10/19/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2019
• Device Model Number: 106
• Device Lot Number: 204163
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 09/24/2021
• Supplement Dates FDA Received: 08/26/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR