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

Model Number 102

Device Problem Battery Problem (2885)

Patient Problems Emotional Changes (1831); Therapeutic Response, Decreased (2271)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Additional information was received stating that the vns patient had a history of severe chronic depression.The patient had a history of electroconvulsive therapy and was prescribed a high-risk combination of medications.The patient had swings of increased depression related to stress.The patient was compliant with her medications.The patient reported that she felt like she was dragging, could tell that her device had stopped working, and could no longer feel stimulation.The psychiatrist stated that the patient¿s medications were maxed and could not be increased.The psychiatrist did not have a programming system, so he could not in interrogate the patient¿s device.The patient reported that when her device was last interrogated, she was told that her battery was depleting.No known interventions have occurred to date.

Event Description

Clinic notes were received indicating that the vns patient was experiencing an increase in depression for the past few months.The patient was referred for generator replacement surgery but no known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

Clinic notes were received which indicated that the vns was interrogated, system and normal diagnostics were performed, previous settings were confirmed and the battery was found to be at end of life.The patient was referred for replacement; however, no known surgical intervention has been performed to date.

Event Description

It was reported that the patient had a vns generator replacement on (b)(6) 2015.The vns generator was unable to be interrogated prior to procedure due to battery depletion.The patient was implanted with a new vns generator and system diagnostics were performed both outside and inside the generator pocket verifying the lead impedance was within acceptable values.The vns generator was interrogated to verify the device was programmed off.It was also reported that the explanted vns generator was discarded at the hospital and will not be returned for analysis.

• 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: 3746197
• MDR Text Key: 4389606
• Report Number: 1644487-2014-00967
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2014

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: 10/31/2008
• Device Model Number: 102
• Device Lot Number: 016389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/21/2014; 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2006
• 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: 60 YR