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 Problems Neck Pain (2433); Unspecified Respiratory Problem (4464)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was seeking explant due to complaints of voice alteration, and pain (pinching from wires).No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that during an x-ray a technician believed they saw a break in her lead.This was not reported by a radiologist.The x-ray was also viewed by the neurosurgeon who reports that he does not see any issues with her leads.At this time there is no confirmation of a lead issue.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11935915
• MDR Text Key: 255425835
• Report Number: 1644487-2021-00761
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

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: 11/04/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female