PULSE GEN MODEL 1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for PULSE GEN MODEL 1000 manufactured by Cyberonics - Houston.

Event Text Entries

[188031203] Patient experienced an increase in seizures. No other relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1644487-2020-00530
• MDR Report Key: 9903271
• Report Source: COMPANY REPRESENTATIVE,CONSUM
• Date Received: 2020-03-31
• Date of Report: 2020-03-31
• Date of Event: 2020-03-06
• Date Mfgr Received: 2020-03-06
• Device Manufacturer Date: 2018-07-16
• Date Added to Maude: 2020-03-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. RACHEL KOHN
• Manufacturer Street: 100 CYBERONICS BLVD SUITE 600
• Manufacturer City: HOUSTON TX 77058
• Manufacturer Country: US
• Manufacturer Postal: 77058
• Manufacturer Phone: 2812287200
• Manufacturer G1: CYBERONICS - HOUSTON
• Manufacturer Street: 100 CYBERONICS BLVD SUITE 600
• Manufacturer City: HOUSTON TX 77058
• Manufacturer Country: US
• Manufacturer Postal Code: 77058
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULSE GEN MODEL 1000
• Generic Name: GENERATOR
• Product Code: LYJ
• Date Received: 2020-03-31
• Model Number: 1000
• Lot Number: 5798
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CYBERONICS - HOUSTON
• Manufacturer Address: 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-31