MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Syncope (1610); Chest Pain (1776); Anxiety (2328)

Event Date 02/22/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced fainting and stimulation throughout the chest when the vns was stimulating.The physician programmed the vns generator off and the symptoms resolved.However, it was reported that during an mri, the patient felt stimulation during an mri and loss consciousness, hitting his head and breaking his ankle.Follow up with the company representative revealed that the patient's magnet output current had not been disabled.The patient reported the stimulation has uncomfortable/painful.The vns was then fully disabled.It was reported that the diagnostics were within normal limits.No additional relevant information has been received to date.

Event Description

X-ray images were received by the manufacturer for review.The m106 generator was placed normally per labeling.The connector pin of the lead appears to be fully inserted inside the connector block due to the position of the back of the pin.The feedthru wires appear to be intact.The lead visibility varies throughout the length of the lead.A strain relief bend and loop appeared to be present.Two tie-downs were present and appeared to be placed according to labeling.No apparent sharp angles or gross fractures were identified in the visible portions of the lead.However, a segment of the lead is behind the generator and the visibility of the lead is lost at the connector pin and these could not be fully assessed.Based on the x-rays received, no indication of a device malfunction was visible.

Event Description

It was reported that the patient's vns had been programmed back on.The patient described the previously reported painful stimulation through his chest as "jolts" that occur randomly.The patient reported that he has panic attacks when he receives stimulation and then faints.The physician opted to not run diagnostics to avoid a fainting spell.The patient has not reported any benefits with vns therapy and was considering explantation.The patient was concerned that the device was faulty.No relevant surgery is known to have occurred to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 7350087
• MDR Text Key: 102786086
• Report Number: 1644487-2018-00426
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2018

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: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 11/28/2018
• Supplement Dates FDA Received: 08/07/2018; 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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: 53 YR