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 Emotional Changes (1831); Anxiety (2328); Sleep Dysfunction (2517)

Event Date 11/30/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported through an article that two depression patients experienced manic episodes believed to be caused by a latent bipolar disorder triggered by the vns.The other patient is captured in mfr.Report # 1644487-2010-02812.Approximately eight months after vns implantation, this patient began to demonstrate manic episodes, cognitive changes, and sleep disturbances that were associated with vns therapy.The patient reported sleeping less than 2-3 hours per night, and he exhibited changes in his interactions with others.He was noted to be exhibiting multiple symptoms of hypomania: logorrhea, disinhibition, displaying mild irritability, and hyperkinetic behavior.No psychotic symptoms were noted.The patient was started on a mood stabilizer regimen of valproic.After this, his manic symptoms appeared to resolve.Follow-up with the patient's treating psychiatrist confirmed that he believed the manic episodes to be caused by the vns and not related to medication.He considered it a serious injury but indicated that the patient was doing well at the time of the report.He said that this was actually a good indication that the vns was working since all anti-depressants have the potential to trigger manic episodes.Prior to his vns implant, the patient had never exhibited any symptoms consistent with mania or hypomania.No further relevant information has been received to date.

• 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: 6394693
• MDR Text Key: 69574588
• Report Number: 1644487-2017-03347
• 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
• Type of Report: Initial
• Report Date: 03/10/2017

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: 05/29/2011
• Device Model Number: 102
• Device Lot Number: 201201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2009
• 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: 58 YR