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

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Weight Changes (2607)

Event Date 09/05/2014

Event Type  Injury  

Event Description

An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events.Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant.One patient had wound dehiscence one week following surgery that was surgically treated.One patient had to undergo surgery to reposition the device due to protrusion.One patient underwent surgery due to a lead issue.Five patients were noted to have experienced significant weight loss due to decrease in appetite.Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help.Two patients were non-responders but experienced significant weight loss that required either device removal or disablement.This manufacturer report involves the patient who experienced significant weight loss that required decrease in device settings.

Manufacturer Narrative

Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis.Aburahma, samah k.Et al.Seizure - european journal of epilepsy.

• Brand Name: PULSE GEN MODEL UNK
• 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: 4377708
• MDR Text Key: 5289694
• Report Number: 1644487-2015-03499
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2014
• 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