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 Problems Chest Pain (1776); Hematoma (1884); Insufficient Information (4580)

Event Date 03/23/2021

Event Type  Injury  

Event Description

It was reported that the patient saw their neurologist to have their stimulation enabled.After this, the patient stated that she feels like she is being stabbed in the neck with stimulation and would like the device disabled.The sales representative was at the clinic visit in which the device was enabled and patient reported to have been able to tolerate the stimulation at that time.Additional information was later received from the patient noting that they had extreme painful stimulation and were having the device explanted due to this.The patient reported suffering from a hematoma post-implant and believed this was the cause of the pain.The patient also posted via social media that the device nearly killed her however it is unclear what adverse event she had in reference to this comment.The explanted product has not been received to date.No additional relevant information has been received to date.

Event Description

Explant product has been received for analysis.

Event Description

Product analysis (pa) for the returned generator was completed.The proper functionality of the device to deliver the programmed output current was verified in the pa lab.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.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.The battery, 2.950 volts as measured during completion of the final electrical test, shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 1.883% of the battery had been consumed.There were no performance, or any other type of adverse condition found with the pulse generator.Pa worksheet was reviewed and no anomalies were found.

Manufacturer Narrative

G3: date received by manufacturer: inadvertently did not mark the date as 5/13/2021 in the supplemental #01 submitted.H2: if follow-up, what type? inadvertently did not mark correction and instead marked additional information in supplemental #01 submitted.

Event Description

Product analysis for the lead was completed.The lead assembly was returned for analysis due to the reported painful stimulation which is outside the scope of analysis.The connector pin has adhesive on the exposed surface at 0.020inches from the small boot o-ring.Other than the above mentioned cosmetic observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Pa worksheet was reviewed and no other anomalies were found.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11724306
• MDR Text Key: 247266169
• Report Number: 1644487-2021-00562
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/09/2021

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: 06/21/2021
• Device Model Number: 106
• Device Lot Number: 205315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Event Location: Other
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 04/19/2021; 06/10/2021; 06/14/2021; 08/16/2021
• Supplement Dates FDA Received: 05/13/2021; 06/10/2021; 06/30/2021; 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR