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

Model Number 1000

Device Problem High impedance (1291)

Patient Problems Twitching (2172); Neck Pain (2433)

Event Date 12/30/2020

Event Type  malfunction  

Event Description

It was reported that the patient has neck spasms and pain.The mother of the patient believes the events are due to vns.Follow-up was performed with the surgeon's office since the patient had a consult and was indicated that cause of the events were unknown; however, the surgeon suspected disruption in the insulation of the vns but has not been confirmed.The patient was referred back to the neurologist to have the device interrogated to check lead impedance and battery status.Information was received that the patient was referred for a lead revision due to high impedance.During pre-op, the generator measured normal impedance, but per the clinic it was high.During the or, troubleshooting of pin reinsertion and testing with test resistor was performed however the impedance value remained the same.It was suspected that the cause of the high impedance was the generator and was related to a generator issue.The surgeon proceeded to replace the generator and the impedance was indicated to be much lower so no lead revision was performed as it was suspected this was a faulty generator.Additional information was received for the or support specialist who attended the surgery indicating that the report of high impedance came from the clinic and that the same normal impedance value was showing even after multiple interrogations were performed.Although the impedance was normal, the physicians and patient decided to proceed with the replacement.The generator was tested with a test resistor inside the or and was showing the expected impedance value indicative of the device functioning.The explanted generator will be sent back for analysis but has not been received to date.Device history records were reviewed.The generator passed final quality and functional specifications prior to release.No additional relevant information has been received to date.

Event Description

Product analysis (pa) for the returned generator was performed.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.The pulse generator diagnostics were as expected for the programmed parameters.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.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The battery, 3.080 volts as measured during completion of the final electrical test, shows an ifi=no condition (ifi range 2.72v - 2.79v).The decoder was reviewed and no anomalies during implant were noted.Diagnostics were reviewed as well.There was no sign of high impedance during time of implant.Wandcomm and the pa worksheet were also reviewed.No other anomalies noted.Based on pa there was no indication of any type of high impedance (>5300 ohms).

Event Description

Product was received into product analysis and is currently ongoing.

Manufacturer Narrative

B5.Event description ¿ correction ¿ inadvertently did not include product received in initial mdr submitted.D9.Device available for evaluation? ¿ correction ¿ inadvertently did not include product received in initial mdr submitted.H3.Device evaluated by mfr? ¿ correction - inadvertently did not include product received in initial mdr submitted and that it is currently undergoing analysis.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11542757
• MDR Text Key: 247283144
• Report Number: 1644487-2021-00387
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2019
• Device Model Number: 1000
• Device Lot Number: 204234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Event Location: Other
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR