MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Dizziness (2194); Convulsion, Clonic (2222); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Patient was referred for battery replacement.Patient was reported to be experiencing increased seizures with postictal dizziness, memory loss and confusion.Patient is having about 10 seizures a week compared to previous 1 seizure a week.It was noted that the patient is presenting with increased seizures as the battery approaches eos.No known surgery has occurred to date.No additional relevant information has been received.

Manufacturer Narrative

Adverse event problem - correction - code e0206 and e0112 were not reported in the initial mdr.

Event Description

The patient had a generator replacement.Per hospital policy, the explanted generator was discarded.No additional relevant information has been received to date.

Event Description

It was reported that the patient's seizures were reported to have improved after battery replacement.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11872465
• MDR Text Key: 252348350
• Report Number: 1644487-2021-00714
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 4822
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR