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

Model Number 106

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

Patient underwent generator replacement on (b)(6) 2019 due to low battery.It was noted that impedance was ok after replacement.The patient then began to experience an increase in seizures and it was noted that the magnet was not effective.During a follow-up outpatient visit high impedance was observed.It was noted that an x-ray was checked and it appeared that the lead pin was possibly slightly disconnected.It was noted that the device was disabled.X-rays were received and reviewed for the patient.The generator was located in the patient¿s upper left chest.The connector pin cannot be seen coming through the second connector block and the end of the connector pin appears to be outside of the generator header cavity.This indicates that the pin has not been completely inserted per labeling.The filter feedthru were confirmed to be intact.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.There was a portion of the lead that was routed behind the generator, and the lead wires were unable to be assessed as intact at the connector pins due to image quality.No sharp angles or gross discontinuities were identified in the visible portion of the lead.Note that the presence of a micro-fracture and/or a lead discontinuity in the obscured portions of lead could not be ruled out.Further information was received that the cause of the magnet not working and the increase in seizures was the high impedance.The increase in seizures was noted to be below pre-vns baseline levels.In regards to intervention, it was noted that the stimulation had stopped due to the high impedance therefore the patient's dose of antiepileptic drugs was increased and the patient was under a "wait and see" approach.It was noted that the believed cause of the high impedance was either incomplete pin insertion or lead breakage due to any factor and that the patient.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent surgery.Impedance prior to surgery was high.Once the patient was opened, the surgeon slightly pulled on the lead and the lead was noted to be fixed and did not come off.The screwdriver was used to loosen the screw and the pin was re-inserted.Impedance was ok.The screw was tightened and the lead was pulled slightly once again and did not come off.The surgeon noted that there might be a looseness of connection between the generator and lead as impedance was ok immediately after surgery on (b)(6) 2019 and then became high after some time had passed.Per the surgeon, the generator was replaced to avoid recurrence of the event.Impedance after generator replacement was ok.X-rays were provided from after the generator replacement surgery.The connector pin can be seen coming through the second connector block for the x-ray received of the patient's replacement generator.Explanted generator was received by product analysis.Product analysis has not been completed to date.

Event Description

Generator product analysis was completed.The product analysis lab did not duplicate the reported pin not fully inserted as a bench lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).Proper lead cavity dimensions were verified in the header area.The reported high impedance was not duplicated in the product analysis lab.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.There were no performance of any other type of adverse events found with the pulse generator.

• 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: 8699463
• MDR Text Key: 148005884
• Report Number: 1644487-2019-01146
• Device Sequence Number: 1
• Product Code: LYJ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: 106
• Device Lot Number: 5962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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: 23 YR