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 03/29/2018

Event Type  Injury  

Event Description

It was reported that the patient was having an increase in seizures.The patient¿s device was at intensified follow up indicator at their latest appointment.The patient¿s seizures have been worse over the past year with 1-2 tonic-clonic seizures/month.The physician did not know the cause of the seizures, or if the seizures were above their pre-vns baseline frequency.Programming history was reviewed for the patient.No anomalies were seen.A battery life calculation was performed, and the device was expected to have 1.3 years to near end of service.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.

Event Description

The patient was replaced due to prophylactic replacement.The explanting facility historically does not return devices, therefore the generator has not been received.No additional or relevant information has been received to date.

Event Description

Information was received that the patient's explanted generator was available for return.The generator was received for analysis but analysis has not been completed on the returned generator to date.

Event Description

The generator was received in end of service condition after being left on after explant.The postburn electrical test results show that the pcba performed according to functional specifications with no anomalies that would impact device performance identified.Internal data was reviewed and no anomalies were identified.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8528559
• MDR Text Key: 142392394
• Report Number: 1644487-2019-00745
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2015
• Device Model Number: 103
• Device Lot Number: 202458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Event Location: Other
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR