MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 03/15/2015

Event Type  Injury  

Event Description

It was reported that a vns patient, implanted since 2014, developed a skin infection in both cervical and chest incisions with a watery discharge, 6 months after the implant.It was reported that after a culture on the biopsy specimen, it was found that there was tuberculosis present.It was reported that the patient got treated for the tuberculosis and was cured from it, but she still has a watery discharge around the cervical and chest incision sites.It was reported that the physician diagnosed the patient as allergic to the vns implant.It was reported that they note that the patient has very good results with vns regarding her epilepsy.No additional information was provided to date.

Manufacturer Narrative

The previously submitted mdr inadvertently provided an incorrect age/ date.

Event Description

It was reported that the vns system works fine and the diagnostic test results are ok.The review of the manufacturing records confirmed the sterilization with the method hp for the generator and the lead prior to distribution.

• Brand Name: PULSE GEN MODEL 103
• 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: 5821849
• MDR Text Key: 50406308
• Report Number: 1644487-2016-01687
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 103
• Device Lot Number: 202685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2013
• 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 Age: 41 YR