MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 10/07/2003

Event Type  Injury  

Event Description

Initially, it was reported that the patient was scheduled for vns replacement surgery.The reason was not provided.It was later reported that the patient underwent a vns system implant because the device had been removed previously due to a (b)(6) infection.Further follow-up revealed that the patient underwent explant in 2004 due to the infection.Attempts to obtain additional information have been unsuccessful to date.

Event Description

It was reported that the patient was hospitalized on (b)(6) 2003.The patient underwent generator explant on (b)(6) 2003 and the patient was discharge from the hospital on (b)(6) 2003.The patient had been hospitalized for systemic sepsis and had a multitude of comorbidities including lung inflammation, pulmonary embolism, boils, acute respiratory failure, heart infection and renal failure.It was reported that the patient was in prison when the patient contracted the illness and the nurse attributed the cause of the sepsis and resulting comorbidities to the unclean prison environment.There was no known trauma or manipulation.The nurse did not believe that vns was related to the infection.The device was explanted prophylactically.The physician believed that having the generator explanted would improve the patient's ability to heal.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative

New information corrects the date of event and date of explant reported in initial mfr.Report.

• Brand Name: PULSE GEN MODEL 101
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3676801
• MDR Text Key: 4260826
• Report Number: 1644487-2014-00678
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2004

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2002
• Device Model Number: 101
• Device Lot Number: 3248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2001
• 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: 36 YR