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

Model Number 106

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Discharge (2225)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's generator incision site had opened postoperatively and that the generator was visible.Patient went to ed and the physician closed the wound under sterile conditions with derma bond.Patient was discharged from the ed with 2 weeks worth of antibiotics.Patient did not report any discomfort but was able to see the generator.Patient was occasionally able to see yellow discharge from the wound.Patient is overall tolerating the stimulation well.No fevers or other signs of infection were present.The chest would was 90% healed with small dehiscence in the center of the wound, exposing the generator.Mild erythema to the wound edge was also present.Vns was interrogated and programmed to 2.0mamp with no lead impedance noted.Due to infection, the patient later underwent generator was explanted on (b)(6) 2016.The explanted generator has not been received to date.A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description

Per clinic notes received, both neck and chest incision nicely healed with no sign of infection.

• 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: 5621104
• MDR Text Key: 44141745
• Report Number: 1644487-2016-00922
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

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: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 203657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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): Required Intervention
• Patient Age: 62 YR