MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

The patient's generator was replaced due to low battery.The generator was returned for analysis.Product analysis was completed on the returned generator.Upon receipt, the generator was pulse disabled due to low battery condition.The generator showed evidence of exposure to electrocautery, there were 11 recorded resets in the internal data of the generator.This indicates that the generator was probably in a high current state in the past.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant which may have been a contributing factor for the reboots.The generator was re-enabled or subsequent testing.The generator performed according to functional testing of final electrical testing with no further anomalies identified.Per the internal data, there were no anomalies beyond 11 recorded resets.The last reset occurred on date of explant.The reason for the most reset was brown out reset (expected per electrocautery).It is unclear if all 11 resets are due to electrocautery usage.No further relevant information has been received to date.

Event Description

Data from date of explant was reviewed.No device resets were logged.Therefore, this indicates all resets occurred due to electrosurgery during the explant procedure.Resets are expected events when the device is exposed to electrosurgery.No further 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
• 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: 12455553
• MDR Text Key: 271035431
• Report Number: 1644487-2021-01283
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2020
• Device Model Number: 1000
• Device Lot Number: 204644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2018
• 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: 21 YR
• Patient Sex: Male