MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Device Inoperable (1663)

Patient Problems Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

Initially, it was reported that the patient's generator was dead and that the patient was experiencing an increase in depressive symptoms.The psychiatrist indicated that the increase in depression was related to vns therapy and that the generator was at near end of service.It is unknown whether the increased depression is an increase above the patient's pre-vns baseline frequency.The patient was referred for surgery.No known surgical interventions have been performed to date.

Manufacturer Narrative

The initial report inadvertently reported information that was not reportable per the manufacturer's procedures and fda reportability guidelines.

Event Description

The patient was referred to surgery due to his vns battery being at end of service.The increased depression was reported to have occurred after the generator stopped providing therapy due to normal battery depletion.There was no allegation against vns therapy.

Event Description

The patient is now known to have had generator replacement on (b)(6) 2016 due to near end of service.The device was reported to be discarded by the explant facility.

• Brand Name: PULSE GEN MODEL 101
• 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: 5150201
• MDR Text Key: 28306205
• Report Number: 1644487-2015-06115
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 10/09/2015

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: 04/30/2002
• Device Model Number: 101
• Device Lot Number: 1623
• 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: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2000
• 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: 56 YR