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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Event Description

It was reported that the when diagnostics were attempted on the patient's vns, error code 254 was observed.The patient was later seen at a different appointment and the same 254 error code was observed.The generator would interrogate, but system diagnostics could not be performed.A cable connection between the wand and vns programming tablet was attempted and error code 43 was seen.A tablet and wand hard reset were performed.Error code 254 was seen again during system diagnostic attempts.The programmer was verified to not be plugged into the wall.Both the company representative's and physician's programmer showed the error message.Emi sources were removed and the wand was rotated 45 degrees.The magnet was swiped for 30 seconds consistently and re-interrogation/system diagnostics were performed.The error code appeared again.The programming tablet data was received and reviewed by the manufacturer.The findings were indicative that the issue was due to a stuck magnet reed switch.A generator reset was performed and low impedance was observed following the reset.The low impedance was a result of the output current not being delivered, which was related to the stuck reed switch.The patient was referred for generator replacement surgery.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

The patient's generator was replaced due to the reported stuck magnet reed switch.Historically the explant facility discards explanted products; therefore, return of the suspect device is not expected to date.No further relevant information has been received to date.

Manufacturer Narrative

Lot #, corrected data: initial report inadvertently listed "na" instead of "204727".Date received by manufacturer, corrected data: initial report inadvertently listed "02/21/2019" instead of "02/20/2019".

Event Description

It was reported that the patient experienced an increase in seizures as he was only able to have the vns therapy titrated to step one of the titration process due to the malfunction.The physician and patient indicated that the increase in seizures was above the pre-vns baseline.A review of device history records revealed that the generator passed quality control inspection prior to distribution.Follow up with the company representative revealed that there was no known trauma to the area of the generator or exposure to magnetic fields.The physician stated that the increase in seizures were "outside of vns" as the patient hadn't been able to be titrated.

• 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: 8429688
• MDR Text Key: 139106502
• Report Number: 1644487-2019-00527
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: 1000
• Device Lot Number: 204727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: 29 YR