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 Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Hypoesthesia (2352); Numbness (2415)

Event Date 08/01/2018

Event Type  Injury  

Event Description

It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips.It was stated that this occurred all of the time.The physician's office stated the diagnostics were within normal limits.The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance.The patient later reported that she had been experiencing problems with her arm and could not move it.No additional relevant information has been received to date.

Event Description

Follow up with the surgeon's office revealed that in addition to the reported numbness, pain, and paresis of the arm, the patient experienced tingling, severely decreased strength, and has had episodes of hypotension.The surgeon and a company representative reviewed the patient's settings, which were not found to be high settings and were, in fact, sub-therapeutic as defined by the manufacturer.The surgeon recommended mri and ct scans to rule out a brain tumor or vagus nerve damage, but it appears that the patient did not undergo the scans.The patient was referred back to the neurologist in order to assess the events further.It was stated that the referral back to the neurologist was both for the patient's comfort and to preclude serious injury.Previous follow up with the neurologist's office revealed that the patient has not been seen since the patient has seen surgeon.

Event Description

It was later reported by the patient she was experiencing arm pain and trouble breathing with stimulation.She stated that her neurologist had informed her that the vns settings were too high.Follow up with the physician's office revealed that, at one point, the patient had wanted the vns removed.However, the patient later stated that she had decided not to removed the vns.The patient no-showed at the latest scheduled appointment at which they planned to do an emg.The physician's office stated that the relation of the numb/immobile arm and its relation to vns was unknown to date.At the patient's last appointment she attended, it was stated that the diagnostics checked out fine and there were no changes to the programmed vns parameters.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8189859
• MDR Text Key: 131166208
• Report Number: 1644487-2018-02378
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2019
• Device Model Number: 106
• Device Lot Number: 204049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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): Other
• Patient Age: 50 YR