MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Chest Pain (1776); Pain (1994); No Code Available (3191)

Event Date 01/31/2019

Event Type  Injury  

Event Description

It was reported that the patient was explanted by the same surgeon who implanted the device.The patient claimed that their provider was not trained well and unfamiliar with the vns, stating that the doctor turned the patient's settings high and the patient reported being in terrible pain for 10-15 minutes while the physician could not figure out how to change settings.After this incident, the patient did not want to continue vns therapy.The device was also protruding outward from the skin and interfering with her clothing.It was reported that the battery had already been dead for a year per the patient when explanted.Information was received via clinic notes and operation notes from the surgeon that the patient was seen due to having issues with the device, notes stating that the patient was experiencing chest pain, shoulder pain, and pain at the device site.The patient stated the device was causing her pain and has been disabled for 5 years.The patient's pain was being managed by oral medication.The patient experienced pain in left shoulder and back of left arm occasionally to starting out as dull and then to sharp pain with movement of the left arm, also stating the device itself was hurting.Operation notes noted that the generator was explanted and discarded.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11095375
• MDR Text Key: 224361199
• Report Number: 1644487-2020-01751
• Device Sequence Number: 1
• Product Code: MUZ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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: 08/22/2014
• Device Model Number: 102
• Device Lot Number: 202332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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: 73 YR