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

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fatigue (1849); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Depression (2361); Irritability (2421); Sleep Dysfunction (2517)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient is not doing well and is more depressed.It was noted that the patient is more irritable with work stress and sleep disruption.The patient was noted to have had thoughts of harming self and tired of feeling depressed.Clinic notes dated (b)(6) 2014 note that the patient is out of the hospital and doing a little better overall.It was noted that the patient is tired and anxious with a lack of motivation.There was no suicidal ideations and the patient was noted to be less hopeless.The notes indicate that the patient has thoughts of giving up.Clinic notes dated (b)(6) 2014 indicate that the patient is doing much better than earlier in the year.

Event Description

The physician reported that the patient's depression and suicidal ideation become worse in the fall and winter.It was reported that medications changes were performed and the patient will be seen more frequently.There was no medication changes that may have caused or contributed to the increased depression or suicidal ideation.The physician indicated that the depression and suicidal ideations are not related to vns therapy and are not worse than pre-vns baseline frequency.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4101882
• MDR Text Key: 4720576
• Report Number: 1644487-2014-02396
• 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
• Report Date: 08/20/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2007
• Device Model Number: 102
• Device Lot Number: 014097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2005
• 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): Hospitalization; Other
• Patient Age: 52 YR