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

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported the patient experienced an increase in depression after the device was programmed off at the patient's request.After the device was programmed back on, the increase in depression continued.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

This information was inadvertently left off of the initial mfr.Report.

Event Description

It was reported the patient's increase in depression was above pre-vns levels.No other additional relevant information has been received to date.

Event Description

It was reported the patient was scheduled for replacement surgery.The surgery took place on (b)(6) 2015 and, prior to explant, the vns system had system diagnostics run which showed the device was working as expected and the battery was no depleted.

Manufacturer Narrative

Adverse event of product problem; corrected data; outcomes attributed to adverse event; corrected data; type of reportable event; corrected data; if follow-up, what type; corrected data; this information was inadvertently left off of the supplemental mfr.Report #02.Evaluation codes - conclusions; corrected data: this information was inadvertently left off of the initial mfr.Report.

Event Description

An implant card was received by the manufacturer which stated the generator replacement was prophylactic as the battery was at a near end of service = no condition.The explanted generator is not expected to be returned for analysis.No other additional relevant information has been received to date.

• 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: 5054539
• MDR Text Key: 25639269
• Report Number: 1644487-2015-05699
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2008
• Device Model Number: 102
• Device Lot Number: 015644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/12/2015
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2015; 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2006
• 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: 37 YR