MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Undesired Nerve Stimulation (1980); Seizures (2063); Swelling (2091); Therapeutic Response, Decreased (2271)

Event Date 10/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient got shocked by a 1500amp electric fence and was rendered unconscious.The patient started feeling painful stimulation at the generator and electrode sites after the electrocution.The physician believed that the tissue around the generator and electrodes may have been burned during the shock, because the patient had swelling at the electrode and generator sites.The physician was unable to run device diagnostics due to the patient having a seizure during the appointment.The physician disabled the patient's device on (b)(6) 2015.The painful stimulation resolved after the device was disabled.The patient was referred for generator replacement surgery, but no surgical intervention has occurred to date.

Event Description

The patient had generator replacement surgery on (b)(6) 2015.The surgeon did not see any indication that the tissue around the generator or electrodes had been burned or damaged in any way.The surgeon also reported that the patient had multiple psychological issues and that the patient made things up to get attention.The surgeon did not believe that there was anything wrong with the tissue or the patient.There was no indication of a device malfunction.The explanted generator was received on 11/30/2015.Analysis identified no performance or any other type of adverse conditions associated with the generator.The generator was returned without the septum, but there was no body fluid observed inside the header septum cavity.This eliminates the possibility of a potential unintended electrical current path through body fluids.

• Brand Name: PULSE GEN MODEL 105
• 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: 5233377
• MDR Text Key: 31514530
• Report Number: 1644487-2015-06485
• 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: 10/24/2015

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: 10/09/2016
• Device Model Number: 105
• Device Lot Number: 203169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/24/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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