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

Model Number 102

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was initially reported on (b)(6) 2015 that the patient reports that his generator is protruding which was confirmed by the treating neurologist.The patient was going to be referred to the surgeon for a possible revision at that time as a result.Additional information later received on (b)(6) 2015 which reported that the patient had an infection and was scheduled for explant on (b)(6) 2015.It was reported that plans concerning the protrusion could be determined at that time and that more than likely the patient's device would be explanted.It was later reported that the patient had generator and lead explant on (b)(6) 2015 due to the infection.Good faith attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of the manufacturer device history records for confirmed sterilization was performed prior to distribution for both the generator and lead.

Event Description

Additional clinic notes were received stating that the patient's seizures were in good control once vns was optimized.Unfortunately,vns became infected despite antimicrobial treatment and had to be removed.Since then, medical management has not been optimal.

• 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: 4694819
• MDR Text Key: 5641572
• Report Number: 1644487-2015-04459
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: 102
• Device Lot Number: 016274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2006
• 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 Age: 26 YR