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

Model Number 104

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

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

Event Date 02/12/2019

Event Type  malfunction  

Event Description

It was reported that the patient was referred for vns replacement due to a low battery.The specific battery indicator was not provided.The patient¿s father was concerned that the battery had only lasted approximately one year and two months and believed the battery prematurely depleted.A estimation of the device's remaining battery life as performed with the programming data currently available to the manufacturer and the results did not support that the battery would have reached an elective replacement indicator (i.E.Ifi, neos, eos).A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.A review of the decoded programming data from the date of implant revealed no sudden drops in voltage.The percentage of battery consumed aligned with the voltage and no anomalies were identified.No additional or relevant information has been received to date.

Event Description

Generator product analysis was completed.The alleged premature end of life was not duplicated in the product analysis, or pa, lab.The diagnostics were as expected.The battery measured 3.080 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition, which corresponded with the diagaccumconsumed value.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.

Event Description

Information received that the patient underwent vns generator replacement surgery.The explanted generator has not been received to date.No relevant surgical intervention is known to have occurred to date.

Event Description

Analysis was completed on the returned lead portion.Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.There was no evidence to suggest an anomaly with the returned portion of the device.Analysis of the generator is currently underway but has not been completed to date.

Event Description

The explanted lead and generator were received.Product analysis is underway but has not been completed 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: 8403722
• MDR Text Key: 138239072
• Report Number: 1644487-2019-00441
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2018
• Device Model Number: 104
• Device Lot Number: 5143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2017
• 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: 20 YR