MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Seizures (2063)

Event Type  malfunction  

Event Description

It was reported by the physician that the patient was seen with daily increased events.No additional relevant information has been received to date.

Event Description

Information was received that the patient's generator was replaced.The explanting facility historically does not return explanted products so device return is not expected.

Manufacturer Narrative

Describe event or problem: initial report inadvertently left off information from the physician.

Event Description

Per the physician, the vns needs replacement as the patient was seen with daily increased events.Information was received that the patient has been scheduled for surgery.No additional relevant information has been received to date.No surgical intervention is known to have occurred to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7876471
• MDR Text Key: 120257497
• Report Number: 1644487-2018-01609
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2013
• Device Model Number: 103
• Device Lot Number: 201761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2011
• 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