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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Seizures (2063); Discomfort (2330); Injury (2348)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported the patient was scheduled for a full revision on (b)(6) 2016.The full replacement is planned because the physician thought there may be something wrong with the system; however, impedance was not high.An x-ray was taken which was reportedly fine.When the vns was programmed off, because the physician thought there was a lead issue, the patient had an increase in seizures, so the device was programmed back on.The patient's family indicated the issue may be related to karate, but there were no issues on what was wrong with the device.It was noted the x-rays would not be released to the manufacturer.Clinic notes were received due to the replacement referral.It was noted the patient sustained an injury during karate sometime in (b)(6).Since the injury in (b)(6) 2015, the patient had intermittently experienced tightness and discomfort in his left pectoral region.The tightness is described as squeezing and occurs every five minutes though this was not observed by the physician while the patient was being evaluated on (b)(6) 2015.The physician was able to recreate the pain by palpating the tissue overlying the vns generator.Diagnostic testing showed an impedance value of 2083 ohms and an ifi = no condition.It was also mentioned at the visit on (b)(6) 2015 that the last pain the patient experienced was 4 days ago.On (b)(6) 2015, the physician decided to program the vns off to attempt to isolate the cause of the pain.It was later noted in clinic notes dated (b)(6) 2016 that the patient's seizures worsened after programming the vns off.Due to the worsening of seizures, the vns was programmed back on.The physician further described he believed the pain was mechanical because the pain does not occur with stimulation, but the pain did occur when the physician palpated the device.Based on this information, along with the impedance value that is within normal limits, the physician believes there is no malfunction with the lead, and only a generator replacement will be needed.The physician explained his plan to revise the generator pocket and secure the new generator more robustly than typical to prevent migration laterally, which is believed to be the etiology of the patient's discomfort.No known surgical intervention has occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Age at time of event; this information was inadvertently incorrectly reported on the initial mfr.Report.Outcomes attributed to adverse event; this information was inadvertently incorrectly reported on the initial mfr.Report.

Event Description

It was reported, through the receipt of an implant card, the patient had generator replacement on (b)(6) 2016 due to mechanical discomfort.

• 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: 5446691
• MDR Text Key: 38558225
• Report Number: 1644487-2016-00353
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 3382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2012
• 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): Other; Required Intervention
• Patient Age: 18 YR