MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Confusion/ Disorientation (2553)

Event Date 06/09/2015

Event Type  Injury  

Event Description

It was reported that the patient woke up with a lump around the generator and was experiencing painful stimulation.The device was programmed off and x-rays were ordered.It was later reported that the patient had a knot over the left neck area and will need to be seen by the surgeon.Clinic notes dated (b)(6) 2015 note that the patient started noticing a knot in the neck the day prior and that the generator was programmed off.It was also reported that the patient was experiencing confusion.No known surgical interventions have been performed.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Further follow-up revealed that the generator implant site was slightly raised.The confusion resolved when the generator was programmed off.There was no patient manipulation, programming or medication changes, or trauma that is believed to have caused the mass and the painful stimulation.X-rays were performed on (b)(6) 2015 which did not identify any adverse vns findings.It was reported that the patient has not yet been seen by the surgeon.No additional relevant information has been received to date.

Event Description

It was reported that the patient was seen by the surgeon who believed the device should be reactivated as there was nothing found wrong with the vns.The physician believes that the vns has been helpful for the patient; however, the surgeon is sending the patient for resective surgery consult.The patient reported that the device is fine, but is nearing end of service.No additional relevant information has been received to date.

• 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: 4893039
• MDR Text Key: 6022498
• Report Number: 1644487-2015-05093
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: 07/31/2008
• Device Model Number: 102
• Device Lot Number: 016066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2006
• 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: 37 YR