MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Pain (1994)

Event Date 11/28/2018

Event Type  Injury  

Event Description

It was reported that the patient was experiencing pain at the generator site, which was at the left armpit due to a chest tattoo.The device was causing discomfort due to being much larger (m106) than the patient¿s previous m103.The patient has a follow-up appointment with the surgeon to discuss moving the vns generator.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient was scheduled for surgery, but the surgery was canceled due to a non-related vns illness.Therefore, the report from the surgeon that he had "replaced the patient's vns at the same place as before" was likely a reference to the initial replacement surgery and not any intervention taken recently.No relevant surgical intervention is known to have occurred to date.

Event Description

Follow up with the physician's office revealed that the surgeon had "replaced the patient's vns at the same place as before." it was unclear what was meant by this and the physician did not wish to provide any further information.

Event Description

The patient underwent vns generator repositioning surgery.A new generator pocket was made towards the middle of the patient's chest.The lead was tunneled to the new pocket, diagnostics were performed, and the patient was closed.

• Brand Name: PULSE GEN MODEL 106
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8181673
• MDR Text Key: 130921813
• Report Number: 1644487-2018-02351
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2019

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: 02/23/2020
• Device Model Number: 106
• Device Lot Number: 5650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/18/2019; 02/22/2019
• Supplement Dates FDA Received: 01/12/2019; 02/11/2019; 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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: 29 YR