MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Syncope (1610); Arrhythmia (1721); Seizures (2063)

Event Date 12/09/2020

Event Type  Injury  

Event Description

The patient reported that recently her vns started to stop her heart and cause her to pass out with stimulation.No other relevant information has been received to date.

Event Description

The patient again reported that the vns shocks her heart and causes arrhythmia, and sometimes she passes out because of it.She also noted that she went to the er on 1/15 because she was having seizures because of "it", seemingly referring to the vns or the heart issues.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11174856
• MDR Text Key: 227059808
• Report Number: 1644487-2021-00065
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: 03/19/2021
• Device Model Number: 1000
• Device Lot Number: 6176
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR