MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930)

Event Date 03/25/2015

Event Type  Injury  

Event Description

It was reported that the patient developed an infection after the vns was implanted.The patient reported that the sutures were removed too soon and the incision opened up.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

(b)(4).Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description

It was reported by the surgeon that there was no infection noted.It was reported that the staples were removed at 10 days and the patient returned days later and 3 staples were replaced for 10 days.The patient is very thin and has thin chest wall.The physician reported that due to the patient's poor wound healing in the past the staples will be left in for 2 weeks if the patient undergoes vns replacement in the future.The patient was prescribed prophylactic antibiotics after re-stapling the incision.The physician indicated that the patient manipulated the generator and lead sites.It was reported that the incision opening was dealt with promptly and that the patient is "skin and bones"; therefore, it was not possible to place the generator with excess skin overtop.Clinic notes dated (b)(6) 2015 note that the generator is palpable but there was no evidence of infection.

Event Description

The patient reported that the lead wire is extruding and that it formed a boil and popped out.The patient is not currently being seen by a neurologist or neurosurgeon as the patient has a history of drug abuse.Mfr.Report # 1644487-2015-05357 previously reported that the patient dug the lead out of her skin and deliberately cut the wire.

Manufacturer Narrative

Describe event or problem, corrected data the following statement was inadvertently not reported in supplemental mdr 1 : "it was reported that the patient had had some inflammation at the electrode site in (b)(6) 2016 and so the patient received an injection of kenalog in the electrode site." the following statement was inadvertently not reported in supplemental mdr 2: "it was reported that the patient's physician had not believed that the patient's lead had extruded from a boil.It was believed that the patient had dug it out of her skin.".

Event Description

It was reported that the patient had had some inflammation at the electrode site in (b)(6) 2016 and, so the patient received an injection of kenalog in the electrode site.It was reported that the patient's physician had not believed that the patient's lead had extruded from a boil.It was believed that the patient had dug it out of her skin.

• Brand Name: PULSE GEN MODEL 105
• 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: 4949590
• MDR Text Key: 6033265
• Report Number: 1644487-2015-05356
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

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: 11/05/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/29/2015
• Supplement Dates Manufacturer Received: Not provided; 04/11/2018
• Supplement Dates FDA Received: 02/26/2016; 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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: 35 YR