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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Organ Dehiscence (2502)

Event Date 12/21/2015

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2015 were received which indicated that on the morning of (b)(6) 2015 the patient's mother had concerns regarding the incision overlying the clavicle.When she was seen in clinic, it was noted that the midportion of this incision had dehisced slightly.Mom states that there has been some drainage.A decision was made to admit the patient for iv antibiotics with concerns that this was only a superficial infection and could, if not treated aggressively, track down and infected the hardware.She therefore was admitted and has been on iv clindamycin in the hospital since that time.The patient did quite well with her antibiotics and her wound improved significantly.There was no drainage since admission.The erythema, that had been surrounding nearly the entire incision, is essentially resolved.It was therefore felt that the patient was stable for discharge to home with oral antibiotics to complete at least a 2-week course.The parents were given instructions to wash this incision daily with soap and water at this point and to keep it dry and open to air as much as possible the remainder of the time.The patient was at a dosing appointment on (b)(6) 2015 and wound looked very good.Grandmother was at appointment and she stated the wound looks 100% better.

Manufacturer Narrative

(b)(4).Additional manufacturer narrative and/or corrected data; corrected data: inadvertently did not include the udi on the initial report.

• 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: 5416989
• MDR Text Key: 37679753
• Report Number: 1644487-2016-00253
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2016
• Device Model Number: 103
• Device Lot Number: 4042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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: 4 YR