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

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Seizures (2063)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient's mother that there was bruising around the incision site after the vns generator and lead were implanted.An additional phone call was later placed by the patient's mother.The patient's mother explained that the patient initially had a decrease in seizures right after surgery, from about 30 seizures/day down to about 5 seizures/day until (b)(6) 2016.On (b)(6) 2016, the patient had approximately 30 seizures, on (b)(6) 2016 the patient had greater than 50 seizures, and on (b)(6) 2016 the patient had nearly back to back seizures.The patient was taken to the er and the patient's following neurologist came down to the er and programmed the patient's vns on.The patient tolerated the stimulations.It was also reported the patient's mother had used the vns magnet to activate the vns several times on (b)(6) 2016 and noted the patient had done ok with the magnet stimulations.However, it was noted that the patient had some blotchiness on her face, neck, and chest but the cause of the blotchiness was unknown.The blotchiness was noted to come and go with seizures, but not all seizures.The dhrs for both the lead and the generator were reviewed and confirmed the devices passed all testing and were sterilized prior to distribution.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Adverse event and/or product problem; corrected data: this information was inadvertently reported incorrectly on the initial mfr.Report.Outcomes attributed to adverse event; corrected data: this information was inadvertently reported incorrectly on the initial mfr.Report.Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr.Report.

Event Description

Additional information was received showing the patient was actually hospitalized for 2 weeks, due to the increased seizures, beginning on (b)(6) 2016.It was also noted the vns magnet was used to temporarily disable to the device; however, it is currently unknown why this disablement occurred.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received from the physician who stated the bruising, increase in seizures, and blotchiness were not related to vns, and the office has since made titrations with no recurrence of the issues.

• 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: 5446622
• MDR Text Key: 39142361
• Report Number: 1644487-2016-00352
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 106
• Device Lot Number: 4553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/14/2016; 05/23/2016; 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: 1 YR