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

Model Number 103

Device Problems Energy Output Problem (1431); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/07/2020

Event Type  malfunction  

Event Description

During a routine follow-up appointment upon interrogating the patient's device, an error message was received which resulted in the patient's device being disabled.Design history record review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.Internal investigated reported that while the root cause is undetermined, the issue appears to be related to temporary power loss within the generator related to an unknown hardware failure that may have contributed to an intermittent loss of power.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient was seen in clinic and there therapy was found to be disabled due to error code 1 (reset code).The patient's device was able to be successfully programmed back on.

Event Description

Internal investigation revealed dendritic growth was observed on the routed edge of the printed circuit board assembly inside a returned affected generator.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process likely promoted an environment conducive for dendritic growth to occur between test points on the telemetry and reset circuits.The probable root cause is considered related to the laser-routing process (manufacturing error caused event).

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11272511
• MDR Text Key: 243642260
• Report Number: 1644487-2021-00139
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2021
• Device Model Number: 103
• Device Lot Number: 205108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female