MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Unspecified Infection (1930); Seroma (2069); Tissue Breakdown (2681)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.(b)(4).

Event Description

It was reported that the patient developed a blister over the vns generator site.It was stated that the patient was to present to the surgeon's office and have the blister drained.Clinic notes were received by the manufacturer.The patient presented to the surgeon's office with a large blister over the corner of the vns generator, which was reported as superficial.The surgeon applied betadine, drained the fluid from the blister, and applied a band-aid.The surgeon felt that the generator had shifted position and was superficial and at risk for extrusion.The surgeon planned for surgery to replace and reposition the generator pocket.Additional clinic notes were received that indicated the patient had an infection since surgery that were being treated with antibiotics and the blister later came up on the implant site.It was later noted that the vns wires were exposed.A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.It was later reported that the patient's mother felt the blister was from the patient's chair, which has a bar across the chest and was rubbing the skin over the generator.The patient underwent vns generator replacement surgery and the generator pocket was relocated to the right side of the chest.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8880755
• MDR Text Key: 153886191
• Report Number: 1644487-2019-01552
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2019

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: 01/30/2021
• Device Model Number: 1000
• Device Lot Number: 204809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2019
• 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