MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

It was reported that the patient's device was interrogated and showed error code 8 (end of service - pulse disabled) and that the vns was turned off.System diagnostics were performed and were ok, and after turning the settings back on, the patient coughed and had voice alteration.The patient's mom noted that voice alteration is normal for the patient and she hadn't noticed it in a while so she thinks that her vns may have turned off on it's own a couple of months ago.Battery was found to be at 50-75%.Based on review of internal data, this event is consistent an event in which the device disables due to eos (end of service) however the battery voltage is not at an eos condition.The cause of the event is due to a transient high current.No other relevant information has been received to date.

Event Description

Information was received that the patient's device was replaced due to "prophylactic" reason per implant form the patient's replacement surgery facility is a no return site therefore attempts for product return will not be performed.No additional 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: 10881692
• MDR Text Key: 217652902
• Report Number: 1644487-2020-01575
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: 07/08/2021

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: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 4322
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR