MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 07/05/2019

Event Type  malfunction  

Event Description

It was reported that a surgeon wanted the patient's generator evaluated by the manufacturer as they suspected the battery depleted prematurely.The generator was replaced prophylactically and the battery status showed 11-25% remaining at the time of the replacement.The device history records were reviewed and indicated the generator passed all functional specifications prior to distribution and the generator was not subjected to the laser routing process per the trim test tab date.The suspect product has not been received by the manufacturer for product analysis to date.Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

Event Description

The generator was received by the manufacturer for product analysis; however, product analysis has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.Diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications and the allegation of premature battery depletion was not duplicated in product analysis.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 8842651
• MDR Text Key: 152688501
• Report Number: 1644487-2019-01475
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2019
• Device Model Number: 106
• Device Lot Number: 204302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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: 11 YR