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 Pain (1994)

Event Date 01/01/2019

Event Type  Injury  

Event Description

It was reported that the patient was having pain in their neck during stimulation, particularly when looking to the left.Additionally, the patient¿s generator had migrated.The patient¿s generator had good impedance with no error messages.X-rays were taken that did not show evidence of a lead fracture.The device was disabled.The xrays have not been received by livanova to date.Per the physician, the patient's migration was due to patient manipulation.The patient's generator migration happened at their generator site, but per the physician the generator ended up back where it was supposed to be.The generator and lead were replaced.The devices have not been received by livanova to date.No additional or relevant information has been received to date.

Event Description

Information was received from the physician.Per the physician, the replacement was due to the painful stimulation.The physician alleged that there may be a lead microfracture, however the lead impedance was fine and chest x-rays were unremarkable.No lead fracture is suspected at this time.The patient's replacement was to preclude serious injury.The generator and lead were received into livanova and product analysis is underway but not complete.No additional or relevant information has been received to date.

Event Description

Product analysis was completed on the generator and lead.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents were verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the pa lab, 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.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.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 portions 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 portions of the device which may have contributed to the stated complaints.Note that since the (+) white electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No additional or 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: 8784749
• MDR Text Key: 150833296
• Report Number: 1644487-2019-01356
• 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
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/10/2020
• Device Model Number: 106
• Device Lot Number: 204358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR