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

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Local Reaction (2035); Pressure Sores (2326)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

Patient went to er over (b)(6) 2016 weekend.Per er physician, vns site was abscessed and so patient is contacting the surgeon.Per the nurse who reported the event, patient stated it felt sore on (b)(6) 2016 and that chiropractor thought he may have tore something.A few weeks later, patient stated they did x-ray and thought it was abscessed.A review of device history records showed that both the lead and generator were sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

Additional information was received regarding the abscess.On (b)(6) 2016, patient was seen by the surgeon, who noted that there was possible abscess near vns lead.Patient developed a small nodule at the lateral edge of his neck incision where the vns lead coursed.Patient was provided clindamycin previously.Physical examination of the neck revealed a quarter centimeter granulomatous nodule in the lateral edge of his transverse neck incision which was consistent with a pyogenicum granuloma.This was debrided with a pair of scissors then cauterized with silver nitrate.On (b)(6) 2016, the surgeon noted that there is a 2 mm bud of granulation tissue that was debrided this was again silver nitrated.On (b)(6) 2016, it was noted that there is a 3 mm of granulated tissue that is flush with the skin at the left chest.The physician cauterized with silver nitrate.On (b)(6) 2016, patient developed a small pyoderma on the lateral aspect of his neck wound.A 3 mm granuloma was cauterized with silver nitrate.It was noted to be improving.The granuloma was reported to be due to infection.On (b)(6) 2016, patient had half a centimeter by 3 mm area of redness along with the granulomatous nodule.The physician planned to place patient on bactrim ds and to excise the granuloma.

Manufacturer Narrative

Device evaluated by mfr: device evaluation is not necessary as a site reaction is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had had his granuloma excised on his left neck in (b)(6) 2017, because they believed it may have been an abscess.However, the cultures came back negative for an infection.In (b)(6) 2017, the patient again came into the office to have an excision of his granuloma and again the cultures came back negative for infection.It late april they could see the lead extruding from the neck, so the patient underwent full explant.The surgeon did not know what caused the granuloma.No further relevant information has been received, to date.

• 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: 6063632
• MDR Text Key: 58654034
• Report Number: 1644487-2016-02504
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2017

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
• Device Expiration Date: 11/06/2017
• Device Model Number: 106
• Device Lot Number: 203634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2016; 05/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• 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): Other
• Patient Age: 29 YR