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

Model Number 105

Device Problem Device Inoperable (1663)

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

Event Date 04/15/2016

Event Type  malfunction  

Event Description

It was originally reported the patient was going to have their vns generator replaced prophylactically.A battery life calculation was performed in (b)(6) 2016, which showed there was approximately 4.5 years remaining until neos = yes (near end of service); however, on (b)(6) 2016, the device itself showed it was at ifi = yes (intensified follow-up indicator).An additional battery life calculation was performed on 11/08/2016, which showed the generator should still have approximately 3.2 years remaining until neos = yes.The most recent diagnostics were run on 05/16/2016 which showed the device was working as intended as the device showed an impedance value of 2112 ohms and was within normal limits.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received noted the patient underwent generator replacement on (b)(6) 2016.Device diagnostics were run prior to the re-implant on (b)(6) 2016, which showed diagnostics within normal limits at 2258 ohms, and an ifi = yes (intensified follow-up indicator) condition.The generator information available within the programming tablets was decoded and reviewed.Based on the information observed within the decoder, the device appears to be performing as intended.It seems the gaps in available information contributed to the discrepancy between the estimated battery life remaining and the actual battery life remaining.No anomalies related to the battery life were identified when reviewing the decoded information.The explanted generator was received by the manufacturer for analysis.While analysis is expected, it has not been completed to date.

Event Description

Product analysis (pa) for the returned generator was completed.The reported ifi = yes (intensified follow-up indicator) condition was duplicated in the pa lab.During pa, the generator diagnostics were as expected for the programmed parameters.Electrical evaluation showed the generator performed according to functional specifications.There were no performance or any other types of adverse conditions found with the generator.

• 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: 6098298
• MDR Text Key: 60292444
• Report Number: 1644487-2016-02630
• 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,Followup
• Report Date: 01/18/2017

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: 09/30/2015
• Device Model Number: 105
• Device Lot Number: 3777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2013
• 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: 54 YR