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

Model Number 106

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient developed staph infection at the generator site that required system explant.The physician indicated that during explant she found signs of infection at the generator site and along the lead.It was reported that the tissue was "like concrete" and required her to cut the lead into pieces to remove it.The surgeon indicated that all of the infection was removed and indicated that prior to, during and after surgery they used several precautions to avoid infection.The surgeon indicated that initially after implant the patient was healing fine; however, over time the redness started and the infection became much worse.No patient manipulation or trauma is suspected to have caused the infection.The surgeon indicated that the patient was very cautious about the incision.The surgeon plans to reimplant the patient when the infection resolves.A review of device history records showed that both the lead and generator were sterilized prior to distribution.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 03/11/2016.There were no performance or any other type of adverse condition found with the pulse generator.Analysis of the lead was completed on 03/21/2016.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description

Clinic notes dated (b)(6) 2016 note that the patient's incisions are all healed.It was noted that the patient would like to proceed with re-implant.The generator will be placed on the right chest given the adhesions on the left chest wall.There is no pain over the patient's scars.

• 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: 5451173
• MDR Text Key: 38691231
• Report Number: 1644487-2016-00381
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2016

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: 06/23/2017
• Device Model Number: 106
• Device Lot Number: 203410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2016; 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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: 21 YR