MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem No Code Available (3191)

Event Date 01/01/2005

Event Type  Injury  

Event Description

It was reported by the patient that her vns had been disabled since 2005 due to it ¿messing with her heart¿.The programming history available to the manufacturer was reviewed for the patient¿s generator.All diagnostics data was within normal limits throughout the available data.Review of the available programming history did not reveal any anomalies that indicated device malfunction.Follow up was performed with the patient's last known treating vns physician.Information was received from the physician¿s office that determined that there was no record of the patient in their system.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8552203
• MDR Text Key: 143210098
• Report Number: 1644487-2019-00785
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2019

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: 01/14/2006
• Device Model Number: 102
• Device Lot Number: 010489
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2004
• 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: 40 YR