MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported extrusion and infection are determined to not be related to vns therapy.

Event Description

It was reported that the patient's lead body was extruding out of the generator site which had occurred a few days before it was reported.The physician stated that it appeared that the patient had picked at the wound at the generator site since the wound had opened up and the lead exposed.The lead and generator were explanted and it was stated that the physician believed the site was infected.No antibiotics were prescribed to the patient for the infection.A review of the device manufacturing records showed that both the lead and generator were sterilized prior to distribution.The patient was referred for an additional surgery to remove the "anchor" which has worked its way out of the generator site and is exposed.No surgical intervention is known to have occurred to date.

Event Description

Additional information was received that the patient had an "anchor" that was removed due to it extruding at the neck incision site for the patient.

Manufacturer Narrative

Unique identifier (udi) # - corrected information: the udi number included on the initial manufacturing report was incorrect and was corrected in this report.

• Brand Name: PULSE GEN MODEL 106
• 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: 7202222
• MDR Text Key: 97628621
• Report Number: 1644487-2018-00112
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 00542502575006
• UDI-Public: 542502575006
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

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
• Device Expiration Date: 06/23/2019
• Device Model Number: 106
• Device Lot Number: 5381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 04/06/2018
• Supplement Dates FDA Received: 02/08/2018; 04/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2017
• 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: 30 YR