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

Model Number 102

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

Patient Problems Anxiety (2328); Depression (2361)

Event Date 06/21/2007

Event Type  Injury  

Event Description

Clinic notes were received for the vns patient's office visit with her psychiatrist on (b)(6) 2007.The patient had been experiencing an increase in depression, anxiety, and mood lability.The patient did not experience any improvement with the previous changes to her device settings.The patient did not experience any pain or discomfort from her device.The patients output current was increased during the office visit.The patient's device was programmed on for the first time at the patient's device was programmed on for the first time at the patient's previous office visit on (b)(6) 2007.It was noted that an attempt was made to taper the patient's medication during the office visit on (b)(6) 2007, which may have contributed to the patient's increased symptoms.The patient's medication was restarted and increased during the office visit on (b)(6) 2007.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014.The explanted device has not been returned to date.

Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #1 inadvertently reported this data, but it was not related to the events previously reported in this mfg report #.Suspect device explant date, corrected data: the supplemental report #1 inadvertently reported this data, but it was not related to the events previously reported in this mfg report #.

• Brand Name: PUSLE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 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: 4092195
• MDR Text Key: 4720365
• Report Number: 1644487-2014-02050
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2007
• Device Model Number: 102
• Device Lot Number: 013476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR