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

Model Number 103

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

Patient Problems Unspecified Infection (1930); Pneumonia (2011); Septic Shock (2068)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.(b)(4).

Event Description

It was reported in a case study article that a patient developed secondary hemophagocytic lymphohistiocytosis (hlh) after a vns wound infection.The article's main hypothesis was that the patient's genetic background played a critical role in the development of this immune dysregulation disease.The patient was implanted at age of 15 and 3 months later had developed a surgical wound infection at the pectoral pocket.At first the generator only was removed and antibiotics were administered for 2 weeks; however after a month the wound infection recurred and the lead was also explanted.The patient subsequently developed septic shock, croup and nosocomial pneumonia and finally evolved to multiple organ failure.(b)(6) was identified and the patient was diagnosed with hlh, the patient was placed on multiple antibiotics in hospital, improved gradually, and was finally discharged after 1 month.The article authors believed the vns surgery acted as an important trigger for the uncontrolled inflammatory response that finally resulted in the secondary hlh.However, no direct links between the vns device as a specific cause of the hlh were made; only that the surgery to implant contributed.No further relevant information has been received to date.Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

• Brand Name: PULSE GEN MODEL 103
• 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: 10022791
• MDR Text Key: 190124074
• Report Number: 1644487-2020-00666
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR