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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported that the recently implanted vns patient developed an infection.During the post-operative period, the patient picked at the generator site and the incision opened.The incision site was re-closed, covered, and healed so the sutures were later removed.During the weekend of (b)(6) 2015, the patient went to the er as she had picked at the generator site and reopened the incision.The lead incision site had healed well; however, the generator incision site was partially opened and the patient¿s generator was exposed.Wound cultures were (b)(6).The patient underwent surgery on (b)(6) 2015 to explant the generator and lead.During the procedure, it was noted that dense scar tissue surrounding the patient¿s nerve.The scar tissue was lysed and the electrodes were able to be removed.The patient has not been re-implanted to date.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.

• 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: 4838570
• MDR Text Key: 5909446
• Report Number: 1644487-2015-04881
• 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: Medical Assistant
• Type of Report: Initial
• Report Date: 05/18/2015

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: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 3993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• 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: 22 YR