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

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016.The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible.The patient's device was then explanted.The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release.The operative report was received from the explanting facility.The patient's wound swelled over the course of a few days and dehisced.The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection.A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well.No further relevant information has been received to date.

Event Description

It was reported that the patient started having redness and swelling at the left neck.The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead.The physician aspirated fluid from the cyst, which was dirty; and looked infected.The patient then had the remainder of the lead explanted.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: 5835493
• MDR Text Key: 50818680
• Report Number: 1644487-2016-01714
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 4792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 11 YR