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

Model Number 102

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Scarring (2061); Impaired Healing (2378); Reaction (2414)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's vns implant surgery ((b)(6) 2015) incisions were not closing.Cultures were taken and there was no infection.Redness, granular tissue masses were reported as well, thought to be due to dead immune tissue in response to the open wound.The tissue was excised and irrigation of the site was also performed.The patient has been referred for device explant because the wounds will not stay closed.It is believed that the patient may have a metal allergy of some other foreign body response which is preventing proper healing of the incisions.No known surgical interventions have occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received that the patient underwent vns explant surgery on (b)(6) 2015, and upon explant infection was noted.It was believed that the infection began in the patient's neck and spread to the patient's generator site.Cultures confirmed the infection was from staphylococcus.This patient's infection was previously reported in mfr.Report # 1644487-2015-06728 as the patient's identity was unknown at that time.Device history record sterility was reviewed and no non conformances were found.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5270831
• MDR Text Key: 32785813
• Report Number: 1644487-2015-06659
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2016
• Device Model Number: 102
• Device Lot Number: 203237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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): Required Intervention
• Patient Age: 17 YR