MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Energy Output Problem (1431); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

It was reported that the physician observed a message indicating the vns programming system and vns generator were incompatible despite not having an issue interrogating the patient in the past.It was stated that the generator was "currently disabled due to wand reset." when attempting to program the vns as intended, the physician had issues with establishing communication, which resolved via troubleshooting and replacement of the wand's battery.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently left out information.(b)(4).

Event Description

A review of device history records revealed that the generator passed quality control inspection prior to distribution.When interrogating the vns after establishing communication after troubleshooting, a low out put current was observed.

Event Description

Follow up by the company representative revealed that upon interrogation of the patient's vns with his programming system, the same disablement message was observed.Diagnostics revealed a low output current.The diagnostics enabled stimulation once again.It was reported that following the clinic visit, the patient felt stimulation while in a store and fell.It was stated that the magnet was taped over the vns to temporarily disable the device.It was later reported by the physician's office that the patient was experiencing painful stimulation that was causing the patient to leap out of bed.It was stated that the magnet was taped over the patient's vns and this had worked temporarily, but then no longer seemed to inhibit stimulation.It had not been verified that the magnet was placed correctly.It was later reported that the patient presented to the er were the magnet was securely taped to the generator.However, the patient reported that it did not stop stimulation and the patient was still receiving stimulation.The patient's vns was interrogated, diagnostics were ran and were within normal limits, and the pulse width was reduced.The company representative stated that the facility had reviewed x-rays and there did not appear to be any issues with the vns.Based on the review of the tablet data received, the magnet swipes increased by 201 swipes from the clinic visit approximately a week prior.Based on the review of the data and the observation of many "magnet swipes", it appeared that a potential cause for the number of magnet activations was due to incorrect positioning of the magnet for magnet disablement attempts resulting in multiple magnet "activations" (since the magnet is programmed to 0.00 ma).Another potential cause was the patient wearing the vns magnet on the wrist or interacting closely with a device that produces a magnetic field.If a wand reset or the wand batteries were replaced at a time when the patient was attempting magnet disablement or interacting with a device that produces a magnetic field and interrogation was attempted shortly after the wand reset/battery replacement, it is possible for the wand to trigger a generator reset.

Event Description

The patient underwent prophylactic vns generator replacement surgery.The explanted product was received by the manufacturer and is pending product analysis.

Event Description

Generator product analysis was completed.The allegation of a generator reset due to a hardware reset was verified in the product analysis, or pa, lab.A hardware (hw) reset was not observed prior to decontamination as received and was not duplicated in the pa lab.The internal data from the generator revealed that the rt cre start time memory location indication a reset date approximately a year after the rtc operating time memory location's estimated fet occurrence, indicating that the device was reset.A root cause for hw reset condition was not determined.Although the reported allegations of ¿stimulation not perceived normal and magnet mode¿, ¿painful stimulation¿, and ¿voice alteration¿ could not be evaluated in the pa lab, proper functionality of the generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab.The septum was not cored and, therefore, eliminated the possibility of a potential unintended electrical current path through body fluids, which addresses the allegation of painful stimulation.The low output current and magnet not inhibiting stimulation allegations were not duplicated in the pa lab.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No signs of variation in the generator's output signal were observed and the diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.The battery measured 3.065 v at the completion of the fet, showing an intensified follow-up indicator, or ifi, = no condition.Multiple magnet swipes were observed in the magnet history log, further confirming the assessment that the magnet was not properly secured in order to inhibit stimulation and instead registered as magnet swipes (trd patient, magnet output current = 0.00 ma).Other than the noted events (hw reset), there were no additional performance or other adverse conditions found with the generator.

Event Description

Per internal investigation of the event and similar events, it is suspected that the resets may be caused by a hardware failure that may have contributed to an intermittent loss of power.No other relevant information has been received to date.

Event Description

Internal investigation revealed dendritic growth was observed on the routed edge of the printed circuit board assembly inside a returned affected generator.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process likely promoted an environment conducive for dendritic growth to occur between test points on the telemetry and reset circuits.The probable root cause is considered related to the laser-routing process (manufacturing error caused event).

• Brand Name: PULSE GEN MODEL 103
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 8728703
• MDR Text Key: 149003481
• Report Number: 1644487-2019-01198
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: 06/19/2023

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: 06/27/2020
• Device Model Number: 103
• Device Lot Number: 204590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/18/2019; 07/23/2019; 09/16/2019; 10/24/2019; 12/21/2020; 05/25/2023
• Supplement Dates FDA Received: 07/18/2019; 08/16/2019; 10/10/2019; 11/18/2019; 01/14/2021; 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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 Age: 67 YR
• Patient Sex: Female