MAUDE Adverse Event Report: CYBERONICS - HOUSTON 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)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

Event Description

It was reported that the patient reported to the clinic with a fever and cellulitis around the vns generator site.A culture was taken.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.Clinic notes were later received from the surgeon.The notes indicated that the lab results form the cultures were moderate staphylococcus aureus.It was reported that the wound was much better and the erythema was essentially completely resolved.It was stated that there was still an open area and the lower part of the incision needed to be packed.The surgical notes included in the clinic notes indicated that the lead incision site was re-opened by the surgeon.No purulence or infection was observed.The incision was irrigated with gu irrigant and antibiotics were placed in the wound.The incision was closed.The generator incision was re-opened by the physician and purulent material was encountered in the pocket.The generator was removed and the portion of the lead in continuity with the generator was removed.The generator pocket was lavaged and then instilled with antibiotic irrigation.The incision was closed except for the caudal centimeter and a half of the incision, which was left open and packed with antiseptic soaked gauze.Sterile dressing was placed about the incision.No additional relevant information has been received to date.

Event Description

It was reported that the patient under surgery to explant the vns electrodes, which were the only portion of the lead remaining implanted, due to the cultures coming back as (b)(6).

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7050156
• MDR Text Key: 92668041
• Report Number: 1644487-2017-04847
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 12/22/2017

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: 07/24/2019
• Device Model Number: 106
• Device Lot Number: 204205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2017
• 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: 64 YR