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

Device Problem Device Inoperable (1663)

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2016

Event Type  Injury  

Event Description

An article was received that reported multiple adverse events and malfunctions.The current report captures the report of infections with vns therapy.Mfr report # 1644487-2017-04683 captures the report of high impedance on the lead.Mfr.Report # 1644487-2017-04685 captures adverse events associated with the lead.The article discusses the surgeon¿s experience and techniques with 30 patients who underwent vns lead removal and in some cases re-implantation.The article also discusses two surgical techniques, sharp dissection and monopolar microneedle electrocautery.It reports that there were 4 patients that had the entire device removed and not re-implanted because of infection.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 6981836
• MDR Text Key: 90389733
• Report Number: 1644487-2017-04684
• 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: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/26/2017
• 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