MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Depression (2361); Cognitive Changes (2551)

Event Date 03/26/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported the patient had an increase in depression, above pre-vns baseline levels.It was later reported that the patient was having suicidal ideations with no desire to follow through.The patient was scheduled for prophylactic vns generator replacement due to clinical symptoms.The vns generator was replaced on (b)(6) 2015.It was noted prior to surgery that the vns system was working properly and there was no device failure suspected.It was noted that after the vns generator replacement surgery, the patient was still feeling "down", but it is unknown if this is due to medications, the patient's adherence to medications, or if it is related to vns therapy.It is unknown if the suicidal ideations have resolved.No additional relevant information has been received to date.The explanted device was discarded by the explanting facility.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5038504
• MDR Text Key: 24387492
• Report Number: 1644487-2015-05599
• 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: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 07/30/2015

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: 11/30/2006
• Device Model Number: 102
• Device Lot Number: 011368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2005
• 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: 68 YR