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

Model Number 1000

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

Patient Problem No Information (3190)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

It was reported the patient was being referred for exploratory surgery and possible lead revision.No additional relevant information has been received to date.

Event Description

It was reported the patient had high impedance observed and was referred for a possible lead revision.It was reported that the patient had a generator replacement; however, no lead replacement occurred.Per the surgeon, the lead wire did not appear to be fully inserted into the generator.No additional relevant information has been received to date.

Manufacturer Narrative

B1.Product problem - correction - product problem was not included on supplemental #1 mdr as device problem occurred due to user error.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10897024
• MDR Text Key: 218173281
• Report Number: 1644487-2020-01595
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2020
• Device Model Number: 1000
• Device Lot Number: 204575
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 01/11/2021
• Supplement Dates FDA Received: 12/22/2020; 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR