MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2014

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient may have experienced some sort of an axillary infection in (b)(6) 2014 from poking and scratching at his device.The patient¿s device was reported to be functioning well at the time.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Clinic notes dated (b)(6) 2014 reported that the patient had been treated for an ¿abscess¿ in the left axillae with an incision and drainage by his primary care physician on two occasions recently.The most recent was about a week and a half prior.The patient denied any antibiotic prescription given.The patient reported that it had returned somewhat.Upon physical examination, there was an approximate 1.5 inch length palpable lesion in the left axillae which was soft but not mobile.There was no redness or skin breakdown.There was no tenderness to palpitation.The physician¿s assessment at that time was that the lesion may represent a sterile cyst versus infection abscess with the infection abscess less likely.Clinic notes dated (b)(6) 2014 reported that the patient had an axillary cyst which had since been drained and appeared to have improved at that point.

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of the generator device history records confirmed sterilization was performed prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3882083
• MDR Text Key: 4593175
• Report Number: 1644487-2014-01529
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 102
• Device Lot Number: 3492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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; Required Intervention
• Patient Age: 27 YR