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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported by a vns patient's implanting physician that the patient's incision on his back had opened.It was noted that only the skin had opened and the generator looked covered.The physician said the intact skin was reinforced with steristrips.The local care for the wound would be provided by patient's parents.Additional relevant information has not been received to-date.

Event Description

Follow-up from the surgeon 10/14/2016 provided that the patient's incision opened right after the surgery due to the patient picking at it.The wound opening was superficial only and healed up after local care.

Event Description

Additional information was received that the patient had experienced pain and resulting agitation post-implantation of vns.Follow up with the patient's neurologist determined that the pain and agitation were due to the patient being autistic and becoming irritated when he noticed the device.Lead impedance was reported to be normal.The neurologist reportedly prescribed tylenol to help, and the issue later resolved.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 5870030
• MDR Text Key: 51923584
• Report Number: 1644487-2016-01805
• 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,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 106
• Device Lot Number: 203814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 18 YR