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

Model Number 106

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Battery Problem: High Impedance (2947); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that during interrogation, the tablet was showing an error code 128.The device was properly troubleshooted (ie.Check wand power (press and release power button), verify wand selection (confirm wand id matches wand selected on programmer), check for interference (confirm wand is 3-4 feet away from electrical equipment including overhead or lights), attempt to reconnect wand, remove and re-insert wand batteries.Another programming system was used in which the error code 128 was identified again; thus making the generator, the suspected malfunctioning product.Error code 128 is indicative of an ipg communication timeout.No other relevant information has been received to date.

Event Description

It was reported that the patient was experiencing an increase in seizures after this report of "error code 128" the error code 128 was detected on multiple programming systems.The patient's increase in seizures resulted in their keppra being increased along w/ scheduled surgery.

Event Description

Tablet data was provided for review.Upon review, an instance of high impedance during the implantable lifetime of the generator was seen.This had resolved spontaneously however.The device was explanted on an unknown date.The explanted generator has not been received into product analysis to date.A review of the log files conducted indicated that the cause of this error code 128 could be related to a communication issue within the programming system rather than an error within the generator.Indicating that there could be some form of interference existing within the environment that could attribute to the event.The rep indicates that the patient was interrogated in multiple different locations with multiple different programming system all with the same result.This remains as speculation.Product analysis testing will need to be performed to confirm this speculation.

Event Description

It was reported that the generator was explanted.The explanted generator has not been received to date.

Event Description

It was reported that the patient's device was received into product analysis.Product analysis testing was performed in which the fault was confirmed in the product analysis lab.During the analysis, a visual analysis was conducted in which contaminates on the trimmed edge of the pulse generator pcba were identified.Probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pulse generator pcba, which contributed to the supply current conditions.The remaining residual material on the pulse generator pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation and may have been the contributing factor for the reported allegations of ¿failure to program¿, ¿no stimulation¿, ¿device failure¿.It was noted that the patient's device was in an end of service condition.This event was previously identified and investigated in a field action carried out in 2017.The device specified in this instance is encompassed by this field action, and therefore the failure is expected given the date in which the "trim test tab" removal was performed.*please note that the previously reported high impedance and failure to program is likely related to the premature end of life event related to the issue with the pcba.These are likely not unique faults and are rather components of the pcba failure.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17185691
• MDR Text Key: 317780820
• Report Number: 1644487-2023-00801
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2016
• Device Model Number: 106
• Device Lot Number: 4382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 07/21/2023; 09/07/2023; 10/30/2023
• Supplement Dates FDA Received: 07/17/2023; 08/15/2023; 10/02/2023; 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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 Age: 31 YR
• Patient Sex: Female