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 Problem Seizures (2063)

Event Date 01/19/2021

Event Type  Injury  

Event Description

A clinical study patient was reported to have experienced a tonic-clonic seizure possibly related to stimulation.The event was reported to be unlikely related to implant procedure.No additional relevant information has been received to date.

Event Description

Per the physician, the change in seizure pattern was seizure attack tonic clonic with face trauma.No other factors contributed to the change in seizure pattern.No additional relevant information has been received to date.

Manufacturer Narrative

B2.Outcomes attributed to adverse event - correction - "other serious" was not checked on initial mdr.H3.Device evaluated by mfr? - correction - "not returned to mfr." was not checked on initial mdr.

Event Description

The change in seizure pattern for the clinical study patient was reported to have resolved.No additional 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: 11287061
• MDR Text Key: 230540308
• Report Number: 1644487-2021-00192
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

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: 10/17/2021
• Device Model Number: 1000
• Device Lot Number: 6479
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 05/07/2021
• Supplement Dates FDA Received: 03/24/2021; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR