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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

It was reported during an initial implant surgery that upon interrogation, the new generator was found to be depleted.The surgeon mentioned that prior to implant, he did not recall the device being depleted and that the end of service indicator was observed after multiple interrogations and diagnostics.Impedance of the new generator was within normal limits.A backup generator was used for the implant.A review of device history records revealed that the generator passed quality control inspection prior to distribution.The explanted device has not been received by the manufacturer to-date.No additional relevant information was received to date.

Event Description

The generator was received by the manufacturer and product analysis is underway but has not been completed to date.No additional or relevant information was received to date.

Event Description

Product analysis was performed and approved for the explanted generator.Burn marks were observed on the generator case, indicating that the generator may have been exposed to an electrocautery tool during the implant procedure.The minimum voltage measured showed 1.786 v, estimated from the day of surgery, confirming the report of the "end of service" indicator.Decoded data from the generator indicated that 1.090% of the battery had been consumed.Battery voltage measured 2.964 during testing, indicating an intensified follow-up indicator = no (ifi=no) indicator.Testing performed on the device showed the generator performed according to functional specifications.Other than the noted "end of service" event, there were no additional performance or any other type of adverse conditions found with the generator.

• 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: 7140641
• MDR Text Key: 95731741
• Report Number: 1644487-2017-05038
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2019
• Device Model Number: 106
• Device Lot Number: 5336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 MO
• Event Location: Operating Room
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 02/15/2018
• Supplement Dates FDA Received: 02/13/2018; 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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 Age: 42 YR