MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Pain (1994)

Event Date 05/27/2014

Event Type  Injury  

Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to pain and repositioning of the generator pocket.The explanted generator was returned to the manufacturer for analysis.Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The generator performed according to functional specifications.During the product analysis, there were no anomalies found with the pulse generator.

Event Description

Additional information was received that the patient experienced neck pain and "intermittent buzzing", which started back in 2014.The buzzing sensation stopped when the patient's generator was replaced in 2014 but the neck discomfort continued to be present.The patient continues to have pain when turning the neck.It is unknown whether the neck pain is related to vns.It was reported by the patient's caregiver that it could be related to a muscle strain.No known interventions were taken regarding neck pain as patient has not consulted a physician regarding this yet.

Event Description

Further follow up indicated that the x-rays appeared normal and the vns device diagnostics were also normal.As the patient is hard to communicate with, the cause of the pain remains unknown and vns was not ruled out to be a possible factor.The x-rays were received and reviewed by the manufacturer.Two sets of electrodes were visualized in the neck region.The superior set of electrodes pertains to the current functional lead that was implanted on (b)(6) 2009 and the inferior set of electrodes belongs to the lead that was partially explanted on 09/10/2009.There did not appear to be any gross fractures or discontinuities that might explain the pain and painful stimulation.

Event Description

Clinic notes dated (b)(6) 2014 note that the patient has experienced a stinging sensation at the generator site.It was noted that the patient feels that the device is still working.It was noted that the patient's mother feels like the generator is slipping lower.It was noted that the vns is causing the patient pain for the last month and that it seems to be slipping down in her chest.X-rays were performed which showed the generator at the left heart border.Attempts to obtain additional information have been unsuccessful to date.No surgical intervention has been performed to date.

Manufacturer Narrative

Event Description

The pain on the left side of the neck was reported to have started a year ago and is not occurring with vns stimulation.Patient was also reported to be wheel chair bound.It was noted that the patient would often turn the head to the right and stretch.X-rays were reviewed by the physician and the lead was observed to be coiled over the base of the left neck and in the mid left neck region.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3900196
• MDR Text Key: 4623537
• Report Number: 1644487-2014-01613
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: 102
• Device Lot Number: 2323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2009
• 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: 20 YR