MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Implant Pain (4561)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the pain related to the presence of the device and is not related to the functionality or delivery of therapy of the device.

Event Description

Implant card was received reporting that the patient's generator was replaced to revise to a smaller generator size.Diagnostics were okay pre-operatively.The patient complained of pocket pain that radiated from the device pocket, both laterally and towards his back.The patient also indicated concerns of the generator migrating more laterally and wanted the device to be moved more medially.However, during revision surgery, migration was not identified.No further relevant information has been received to date.Device evaluation is not necessary as the pain related to the presence of the device and is not related to the functionality or delivery of therapy of the device.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13025665
• MDR Text Key: 282394795
• Report Number: 1644487-2021-01764
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

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: 06/02/2021
• Device Model Number: 106
• Device Lot Number: 204954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2019
• 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: 37 YR
• Patient Sex: Female