MAUDE Adverse Event Report: CYBERONICS - HOUSTON; GENERATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Death (1802); Scar Tissue (2060); Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 09/01/2010

Event Type  malfunction  

Event Description

A voluntary medwatch was submitted to the fda and received by the manufacturer with the report number mw5062653.It was reported that after the patient's initial vns implant, which occurred on (b)(6) 2010, that the patient had worsening depression and the device malfunctioned and could be fatal.It was noted that this first implant was constantly malfunctioning and left scar tissue, which caused death/resuscitation in the operating room.It was reported the device caused a stroke two times, and caused permanent damage to the heart/body.The manufacturer's internal databases were reviewed; however, the patient information was unable to be identified based on the lack of information reported on the voluntary medwatch.Additional information related to a second implanted vns is captured in mfr.Report # 1644487-2016-01519.

• Brand Name: NI
• 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: 5772209
• MDR Text Key: 49647774
• Report Number: 1644487-2016-01518
• 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: Other
• Type of Report: Initial
• Report Date: 06/29/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Required Intervention