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 Date 05/29/2018

Event Type  malfunction  

Event Description

Clinic notes for the patient were received.It was noted that the patient came in during a visit complaining of pain at vns generator site as nephew hit her at this site leaving bruising.The patient indicated they were concerned with vns working properly as they were having an increase in seizures.The patient also reported shortness of breath with stimulation.The device history record's of the generator was reviewed.The generator passed final quality and functional specifications prior to release.No additional relevant information has been received to date.

Event Description

Additional information was received that per the physician, the patient suffers from mental issues and most of the adverse events reported are only in the patient's head.It was indicated that there have been no issues with the patient's vns device and has been working as intended.It was indicated that this was all the information the physician wished to share in regards to the patient.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9531302
• MDR Text Key: 183503647
• Report Number: 1644487-2019-02527
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2015
• Device Model Number: 103
• Device Lot Number: 202565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2013
• 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 Age: 43 YR