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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); Disability (2371)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s had been disabled seven years ago due to anxiety.However, the patient believes electric hair clippers or the car door opener had programmed the device back on.No further information relevant to the event has been received to date.

Event Description

Additional information was received that the patient was referred for explant surgery.Clinic notes were received stating that the patient attended a surgical consult with the chief complaint of wanting the vns system removed.It was stated that the patient is concerned that an anti-theft system on his new car caused the stimulator to be turned back on after having been disabled for approximately the past 7 years.The patient reportedly has not had his vns interrogated since purchasing the new car.No known surgical interventions have occurred to date.

• Brand Name: PULSE GEN MODEL UNK
• 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: 4549218
• MDR Text Key: 16081191
• Report Number: 1644487-2015-03982
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/01/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2015
• 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): Required Intervention
• Patient Age: 60 YR