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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problems Emotional Changes (1831); No Code Available (3191)

Event Date 09/22/2019

Event Type  malfunction  

Event Description

It was reported that the patient had been more restless since having he device, but even more so since the last settings adjustment.The physician reported that the patient was coughing, had an appearance of shortness of breath and had a significant increase in irritability.The device was programmed off.The physician indicated that the irritability being related to the vns was his theory it was reported that there was a high output current message 0.75 ma when the patient was programmed to 0.5 ma.When the tc tried to interrogate the patient's device, he observed the following information: "the output current is not being delivered appropriately" upon initial interrogation." the tablet data was reviewed by the manufacturer.Log file review revealed that error code 254 was observed multiple times during interrogations on.This message is associated with a reed switch failure.Review of data also found that the run state of the device on was "stim inhibited" also consistent with a stuck reedswtich.The high and low output current was due to the reedswitch being closed and the generator having to pull stale values to determine current delivered rather then delivering a new current.Rapid magnet swipes in succession and device reset were unsuccessful to stop the issues believed to be related to the reed switch failure.The patient reportedly continued to cough and choke even though the device was turned off.The patient reportedly ended up in the emergency department due to the adverse events related.The manufacturer's device history records of the m1000 were reviewed.The generator passed final functional and quality specification prior to release.The generator was replaced due to reed switch failure and returned for analysis.Analysis has not been completed on the generator to date.

Event Description

Product analysis was completed on the returned generator.The reported magnet malfunction/ reed switch closed was not duplicated during analysis.Magnet application and electrical testing of the generator showed that the reed switch was operating properly.The generator performed according to functional specifications with no anomalies identified.Review of the internal data of the generator identified that there were 15 magnet inhibitions on (b)(4) 2019 and 5 magnet stimulations and afterwards no magnet activity.It can be concluded that the reedswitch stuck on that date.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9206531
• MDR Text Key: 163918514
• Report Number: 1644487-2019-02019
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: 03/21/2021
• Device Model Number: 1000
• Device Lot Number: 6190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 7 YR