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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 07/08/2019

Event Type  Injury  

Event Description

The physician reported that a patient was having therapy related pain.There was no high lead impedance, and per the physician the patient's x-ray looked normal; however, the physician still believed that there may be something wrong with the generator.The sales representative visited the patient in the hospital to check the device.The sales representative reported that the system diagnostics were within normal limits.Clinic notes were later received confirming that the patient had been referred for generator/lead revision to upgrade to a m1000 sentiva generator.The clinic notes were reviewed and mentioned that the patient continues to have intermittent chest pains.The physician noted that the plan for the reported pain was to refer the patient to the surgeon for replacement.No other relevant information has been received to date.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong aware date.

Manufacturer Narrative

Device available for evaluation?", corrected data: follow-up report #1 inadvertently did not list receipt of the explanted product.

Event Description

The explanted lead and generator were received by the manufacturer.The generator and lead were explanted and returned due to reported pain and painful stimulation.A comprehensive automated electrical evaluation of the generator showed that the pulse generator performed according to functional specifications.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Additionally, it was confirmed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.There was no performance, or any other type of adverse conditions found with the pulse generator.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Other than a slice mark and cut out hole found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing, there were no obvious anomalies found.What appeared to be white deposits were observed in various locations.Energy dispersion spectroscopy confirmed that these deposits contained silicon, phosphorus, sodium, magnesium and calcium.The setscrew marks found on the lead connector pin 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, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No other relevant information has been received to date.

Event Description

An implant form was received confirming that the patient's generator and lead were explanted and replaced due to "pain in neck and chest during stimulation." the explanted product has not been received to date.A response was also received from the patient's physician confirming that the reason for generator replacement was painful stimulation.The physician did not clarify if the surgery was for comfort reasons or to preclude a serious injury.No other relevant information has been received to date.

• 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: 8855009
• MDR Text Key: 153091123
• Report Number: 1644487-2019-01488
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup,Followup
• Report Date: 09/27/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 4814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 09/04/2019; 09/23/2019
• Supplement Dates FDA Received: 09/04/2019; 09/27/2019; 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 21 YR