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 Problems Hypoesthesia (2352); No Code Available (3191)

Event Date 05/31/2017

Event Type  Injury  

Event Description

A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest.The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes.However, the physician noted there was no migration of the device and was fine.The explant occurred for the patient comfort as she simply wanted it removed.It was also reported the patient believes the device was causing her psoriasis.Explant surgery occurred.The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.

Event Description

Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns.The provider states the vns was working for the patient.Analysis was completed for the returned generator.Functionality of the generator to provide the programmed output currents was successfully verified.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Analysis was completed for the lead.The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portions were performed, and no discontinuities were identified.There is no evidence to suggest an anomaly with the returned portions of the device.

• 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: 6666114
• MDR Text Key: 78343714
• Report Number: 1644487-2017-04038
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 203335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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: 34 YR