MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Undesired Nerve Stimulation (1980)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator.Clinic notes indicated that the patient had had some pain at the generator site since the procedure.She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm.After she turned her generator off, her symptoms improved.She continued to have daily auras and seizures and had the worst period of seizures that she's had in years.For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results.The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation.The issues resolved when the device was turned off, but the patient's seizure rate increased because of this.The surgery was indicated to be due to medical necessity.The patient was replaced due to painful stimulation.Lead impedance issues were not detected prior to the replacement.Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery.No further relevant information has been received to date.The suspect product has not been received to date.

Event Description

The explanted generator was received and underwent product analysis.The generator was monitored for 24 hours in a simulated body temperature environment and was able to provide the intended therapy for the entirety of the monitoring period.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.Per a comprehensive electrical evaluation, the generator performed according to functional specifications with no anomalies found.The generator's internal data was reviewed.It was found that while the patient's generator was on, the patient received 21 autostimulations per day.Different autostimulation sensitivities and thresholds were not tried outside of the appointment.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6668568
• MDR Text Key: 78440666
• Report Number: 1644487-2017-04044
• 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
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2019
• Device Model Number: 106
• Device Lot Number: 204027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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: 37 YR