MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Pain (1994)

Event Date 01/19/2018

Event Type  Injury  

Event Description

Clinic notes were received for patient's generator replacement referral.Per notes , the physician noted tenderness on the chest wall when the vns was interrogated.Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest.At the surgeon's consult appointment, the surgeon mentioned that the patient was ok.The surgeon has deferred repositioning the device.No known surgical interventions have occurred to date.

Event Description

Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation.Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness.The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device.The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders.The physician reported that the surgery was not planned for the pain.The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason.No known surgical interventions have occurred to date.

Event Description

It was later reported that the patient was being referred for vns explantation surgery due to the pain in her neck and shooting arm pain.Clinic notes received indicated that the patient presented to the emergency room due to pain on the left side of her neck, which caused the patient to worry that her device had moved.The er physician's assessment was that the device had not moved.The patient also stated that she continued to have shooting pain in her left arm, which was previously assessed to be unrelated to vns, and, with the continued symptoms, would like the vns removed.The patient was prescribed norco for the pain.Follow up with the patient's physician revealed that the neck pain was related to radiculopathy (range of symptoms produced by the punching of a nerve root and, therefore, unrelated to vns) and that the patient was referred for nerve testing and neurosurgery, but that the patient does not want the vns explanted.As the events were found to be unrelated to vns therapy, no further reports will be made as to the reported adverse events unless indicated that the event is related to vns.

Event Description

It was reported that the nerve testing to which the patient was referred was fine and no issue could be found with the vns.Follow up confirmed that the physician's previous assessment that the events were unrelated to vns had not changed.As the events were found to be unrelated to vns therapy, no further reports will be made as to the reported adverse events unless indicated that the event is related to vns.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7318737
• MDR Text Key: 101671330
• Report Number: 1644487-2018-00346
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2015
• Device Model Number: 103
• Device Lot Number: 3832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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: 39 YR