MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem High impedance (1291)

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

Event Date 01/09/2019

Event Type  malfunction  

Event Description

A patient's explanted devices was returned to the manufacturer and it was later reported that the patient passed away, and is likely the reason the patient's generator was explanted and returned to the manufacturer.Product analysis (pa) was completed and reviewed for the patient's devices.Per the device history data, the patient's device experienced a change from normal to high impedance on (b)(6) 2019.There were no other anomalies found with the generator.The patient was reported to have passed away in (b)(6), however the patient's exact date of death and explant date are both unknown, and therefore it cannot be confirmed that the patient's device did not have high impedance prior to death/explant.Lead pa revealed no anomalies with the returned portion.No additional relevant information has been received to date.

Event Description

Information was received that the patient's exact date of death was 12/31/2018.It can be confirmed that the patient's device did not have high impedance prior to the patient passing, and the high impedance that was seen is associated with the patient's death and the explant of the device.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8684700
• MDR Text Key: 148017576
• Report Number: 1644487-2019-01110
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575004
• UDI-Public: 010542502575004
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 07/02/2017
• Device Model Number: 104
• Device Lot Number: 203513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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: 73 YR