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); Septic Shock (2068)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patients generator was replaced due to protrusion and infection, reported in mfr.Report # 1644487-2020-01174.The cause of the infection was related to patient manipulation or trauma per the physician.After the replacement, it was reported that the patient was hospitalized with a massive infection and the vns generator would be removed.It was stated that the patient spent 3 days in the picu and had a bedside procedure to drain more of the infection.The patient developed a bacterial infection in his blood due to hospital acquired actinobacter baumii.The patient was noted to have almost constant uncontrolled seizures.The infection was noted to be controlled.Additional information was received that per the physician, the increase in seizures was due to the infection and was below pre-vns baseline levels.The generator and lead were explanted.Device return and evaluation is not necessary because the reported events are not related to the functionality or delivery of therapy of the device.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.No other 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: 10551802
• MDR Text Key: 207510803
• Report Number: 1644487-2020-01173
• 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: 09/17/2020

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: 03/10/2022
• Device Model Number: 1000
• Device Lot Number: 205243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2020
• 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; Required Intervention
• Patient Age: 14 YR