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 12/01/2015

Event Type  Injury  

Event Description

It was reported by the physician's assistant that the patient was referred for prophylactic generator replacement due to painful stimulation the patient was experiencing.System diagnostics were unable to be performed due to the pain the patient would experience while running the diagnostics, so x-rays were taken.The x-rays were reviewed by company representative and based on the images the cause for the patient's painful stimulation could not be determined.There did not appear to be any gross fractures or discontinuities.However, the portion of the lead not visualized that would be in the chest could not be assessed; therefore, a lead fracture in that portion of the lead couldn't be ruled out.The presence of a micro-fracture could also not be ruled out.On the date of surgery, after the patient was put under, system diagnostics were run on two occasions with the patient's neck turned in different direction.The diagnostics showed the device was functioning as intended and no high impedance was detected.The surgeon decided to only replace the generator since there was no evidence that the leads had any issues.Surgery was completed on (b)(6) 2016.No additional relevant information has been received to date.

Event Description

Product analysis (pa) for the returned generator was completed.During analysis if was confirmed that the septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period.The generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.

• Brand Name: PULSE GEN MODEL 102
• 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: 5850759
• MDR Text Key: 51275171
• Report Number: 1644487-2016-01758
• 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: 07/07/2016

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: 01/31/2009
• Device Model Number: 102
• Device Lot Number: 016932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2007
• 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: 52 YR