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

Model Number 1000

Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)

Patient Problems Headache (1880); Convulsion, Clonic (2222); Fibrosis (3167)

Event Date 05/26/2022

Event Type  Injury  

Event Description

It was reported that patient was seen in clinic with high impedance and low output current.Patient also complained of some headaches and break through seizures.They took x-rays.Per the surgeons notes, impedance was within normal limits after replacement surgery 3 months ago.It was also noted that the patient may have fallen and damaged lead.Patient had surgery, where lead pin was removed from generator and tissue was found at insertion site.They removed the tissue, re-inserted the pin and high impedance was resolved.The high impedance was caused by surgeon error of incomplete pin insertion during previous replacement surgery.X-rays have not been reviewed by manufacturer to date.No other relevant information has been received to date.

Event Description

During the patient¿s revision surgery, the pin was removed and tissue was found at the insertion site.The surgeon(s) believed the tissue had grown into the header of the generator since the patient¿s most recent surgery, and it was not believed to be residue from the earlier procedure.The tissue was removed, the pin was re-inserted and impedance was within normal limits.This will still be reported as incomplete pin insertion as the cause of the observed high impedance, with a root cause of user error.Even though it is believed that the tissue grew into the header in between surgeries (only 3 months in between these surgeries where it was reported that the tissue grew into the header), it is not expected that tissue growth would dislodge the lead pin from the generator and cause high impedance, if the pin were inserted and tightened properly.Proper pin insertion and troubleshooting steps for when high impedance is observed captured within the physician¿s manual.Per previous investigation (b)(4), incomplete pin insertion, is the second most common type of issue related to high impedance or all true-known high impedance events and are usually observed within the first year after surgery has taken place.No other relevant information has been received to date.

Event Description

Ap chest and neck x-rays were received and reviewed.The x-rays were provided after report of high impedance, painful stimulation, dyspnea, coughing, and increased seizures were reported.The generator placement could not be assessed due to scope of x-ray.Based on the images provided, the feedthrough wires were intact, and the pins could be visualized to be not fully inserted.The lead was visualized in the chest and neck.There appeared to be a strain relief bend present; however, the strain relief was not placed per labeling as there was no loop.There were two visualized tie downs present; however not placed per labeling.A portion of the lead was visualized to be behind the generator.The lead was assessed for fracture and discontinuities on the visible portions of the lead however none were noted.Based on the x-rays received, the cause of high impedance can be attributed to incomplete pin insertion; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14755653
• MDR Text Key: 294406020
• Report Number: 1644487-2022-00743
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2023
• Device Model Number: 1000
• Device Lot Number: 205568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Female