MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Low Battery (2584)

Patient Problems Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Swelling (2091)

Event Date 01/27/2015

Event Type  Injury  

Event Description

It was reported that the vns patient developed an infection at the generator site following generator replacement surgery on (b)(6) 2015 due to low battery.The generator site was found to be swollen, red, and oozy during an office visit on (b)(6) 2015.The patient was subsequently given antibiotics and the infection later resolved.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description

Clinic notes were subsequently received indicating that the patient experienced a post-operative infection (left chest)/incisional abscess at the site of the vagal nerve stimulator pocket on (b)(6) 2015.It was described that unspecified conservative therapy had been attempted but was unsuccessful.The patient underwent incision, drainage and debridement of the left chest wall incision on (b)(6) 2015.It was stated that a wound vac was placed and the patient was treated long-term with antibiotics.The wound vac was discontinued at a later date and antibiotic treatment was continued.

• Brand Name: PULSE GEN MODEL 103
• 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: 4719619
• MDR Text Key: 5746508
• Report Number: 1644487-2015-04529
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 103
• Device Lot Number: 203044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• 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: 38 YR