MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Use of Device Problem (1670)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Shock (2072)

Event Date 07/02/2016

Event Type  malfunction  

Event Description

It was reported that the patient experienced constant stimulation since 2 days ago.Patient visited the er regarding this and requested if tc could visit and disable the vns device.Patient was informed on how to use the magnet to disable the device instead.Clinic notes were received for patient's generator replacement referral.Notes dated (b)(6) 2016 indicated that the patient's vns device was interrogation and adjusted without incident.Patient tolerated the new settings.Diagnostics and lead checks were done without incident.Per note dated (b)(6) 2016, patient experienced pain around the vns that is a shock feeling on a nerve.Patient underwent prophylactic generator replacement on (b)(6) 2016.The explanted generator has not been received to date.Additional relevant information has not been received to date.

Event Description

The explanted generator was received on 7/28/2016.The reported ¿continuous stimulation¿ allegation was not confirmed in the pa lab.Test bench analysis of the device¿s output waveform utilizing an oscilloscope (especially to measure signal on and off times), which also included magnet placement (cyber watch) to inhibit the output waveform was performed.The pulse generator performed within specification requirements.Additionally, in the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Event Description

Additional information was received that the patient's pain and feeling of constant stimulation began approximately on (b)(6) 2016.The generator replacement was planned as intervention for the pain and perception of constant stimulation and for prophylactic reasons.The surgical intervention was planned for patient comfort and not to preclude a serious injury.The physician reported that the cause of pain was due to presence of device.Although there is not evidence of battery depletion, the physician reported that the believed relationship of the constant stimulation to vns therapy is battery depletion.A dcdc - 6 was reported to have been observed for diagnostics.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 5824050
• MDR Text Key: 50515818
• Report Number: 1644487-2016-01695
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

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: 09/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1290
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2016; 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2005
• 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: 41 YR