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 01/01/2019

Event Type  Injury  

Event Description

It was reported that the patient was underwent vns generator replacement surgery.The replacement reason provided was prophylactic on the implant and warranty registration form received.It was also reported that the patient fell on her chest in january and, since the fall, could feel the generator moving and experienced painful stimulation with every stimulation.A review of device history record revealed that the generator passed quality control inspection prior to distribution.Follow up with the surgeon's office revealed that the surgeon stated that a suture had to be removed intraoperatively and, therefore, the device was not able to move in the patient's chest.During attempts at product return, it was revealed that the explanting facility does not return explanted products without a signed form.No additional relevant information has been received to date.

Event Description

Follow up with the physician's office revealed that the surgical intervention was to preclude serious injury.The explanted product was received by the manufacturer.Generator product analysis was completed.The allegation of migration could not be evaluated.Although the alleged painful stimulation could not be evaluated in the product analysis, or pa, lab environment, proper functionality of the generator in its ability to deliver appropriate programmed output currents was successfully verified.The septum was not cored, eliminating the possibility of an unintended electrical current path through body fluids.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No signs of variation were observed in the generators output signal and the diagnostics were as expected.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8717155
• MDR Text Key: 148618638
• Report Number: 1644487-2019-01182
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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: 02/29/2020
• Device Model Number: 106
• Device Lot Number: 204419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• 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: 57 YR