MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Muscle Spasm(s) (1966); Hypoesthesia (2352); No Information (3190)

Event Date 06/23/2014

Event Type  Injury  

Event Description

It was reported by the physician and the patient that the patient was referred for explant as the patient experienced a lack of efficacy and the vns wasn't worth the side effects.It was also noted the device was programmed off months ago and the patient did not experience an increase in seizures due to the vns having been programmed off.A battery life calculation was performed on 01/05/2017 and reviewed on 01/10/2017.The in-house programming history database contained information from 07/30/2014 through (b)(6) 2014.No anomalies were noted and the impedance was within normal limits.Based on the information provided, and the parameters/diagnostic history found within the vns therapy programming history database, the patient had approximately 10 years remaining until neos = yes.The programming history database was reviewed on 01/10/2017.The database contained programming history from 07/30/2014 through (b)(6) 2014.No anomalies were noted.The patient was last programmed on (b)(6) 2014.The last diagnostics were performed on (b)(6) 2014 and showed the device was working as intended.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was later received from the physician's office.It was noted the patient experienced neck flexes and tingling.It was noted the something (the information was illegible) was ineffective in aborting seizures from 2014-2016.It was also noted that the output current had been decreased over 2014 and 2015 due to the reported side effects.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6238631
• MDR Text Key: 64389790
• Report Number: 1644487-2017-03007
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

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: 05/31/2015
• Device Model Number: 103
• Device Lot Number: 202541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 17 YR