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

Model Number 102

Device Problem Programming Issue (3014)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/01/2016

Event Type  Injury  

Event Description

It was initially reported the patient was referred to have his device removed; however, the reason was unknown.During investigation it was noted the patient's device had been programmed off for over 5 years and the vns was now " bothering him", which is why he was having the device explanted.The programming history database was reviewed, which provided information from (b)(6) 2008.No anomalies were noted within the data available and the device was working as expected.A battery life calculation was performed which showed the battery would have been depleted approximately 5 years ago.Further investigation showed that " bothering him" meant that when he turned his neck there is discomfort and when he lies on his side, it feel like the generator is shifting.Attempts for additional informational relevant information have been unsuccessful to date.

Event Description

It was clarified that the patient's discomfort occurs when he turns his neck and also when he lays on his side, it feels like the generator is shifting.Attempts for additional relevant information have been unsuccessful 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: 5924125
• MDR Text Key: 53782468
• Report Number: 1644487-2016-01976
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2007
• Device Model Number: 102
• Device Lot Number: 012303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2005
• 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: 19 YR