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 Chest Pain (1776); No Code Available (3191)

Event Date 09/01/2017

Event Type  Injury  

Event Description

Clinic notes were received for generator replacement referral.Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer.At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing).It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires.Patient also feels a wire present near the attachment to the device which was not noticeable to her previously.Patient has not had any injuries or falls which may have damaged the device.Patient compares this to a similar feeling she had before the batter was replaced previously.Patient's device was interrogated but no adjustments were made.The patient consulted with a surgeon who indicated that a generator replacement is recommended.The lead impedance was normal and so lead replacement is not needed.Impedance - 2424 ohms.The surgeon noted granulation tissue or lead wire close to the skin in the chest area.The incision was however well healed.No other relevant information was received.No known surgical interventions have occurred to date.

Event Description

Additional information was received that the surgery was for patient comfort.There were no causal or contributing factors that preceded the painful stimulation and the report of erratic stimulation.The reported protrusion was confirmed invalid and thought to be patient's perception.There was no wires on exam like reported.Patient's settings were provided but diagnostics were not.The patient underwent generator replacement surgery.The explanted device was discarded.

• 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: 6949677
• MDR Text Key: 89344880
• Report Number: 1644487-2017-04601
• 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
• Report Date: 11/14/2017

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: 06/27/2014
• Device Model Number: 103
• Device Lot Number: 3495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2012
• 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): Required Intervention
• Patient Age: 25 YR