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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2019

Event Type  malfunction  

Event Description

It was reported that a m106 generator stored in the hospital's "stock" was dead upon initial interrogation.It was mentioned that over 25 interrogations were performed, and then they attempted several more interrogations with the lead connected.It was noted that they had the wand placed directly over the generator, however they kept receiving a "generator not found" message.Further follow up confirmed that the generator was unable to be interrogated while it was still within the sterile packaging.After three failed attempts with the m106 generator, an interrogation of a m1000 generator was attempted with no issue.It was noted that electro-surgery tools were used to open the patient to remove the old device, however by the time the generator was removed from the sterile packaging and placed in the patient, there were no electro-surgery tools in the field.It was confirmed that the generator was stored in the implant room at the hospital, and the conditions of the room were exceptional, described as room temperature and dry.A review of the device history records confirmed no unresolved non-conformances for the generator, and confirmed that the device met all specifications for release prior to distribution.Additionally, it was confirmed that the device was not manufactured with the laser routing process that left certain devices susceptible to premature battery depletion.The generator was received for product analysis.Analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

The generator was explanted and returned to the manufacturer due to premature end of life.Product analysis was performed on the explanted generator to determine the root cause of the reported battery depletion.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 0.757 volts, confirming an end of service condition.The resistance, between the pins 17 and 18 of the a1 microprocessor, was erratic measuring approximately 40k ohms ¿ 50k ohms.The pcba was connected to a bench power supply and set to 3 volts.The ¿supply current wait¿ measured approximately 3.6ua.The foreign matter particle, as found, did not have an effect on the amount of current the pcba consumes.An interrogation and system diagnostic test were performed, with a distance of one and one-quarter inches between the pcba and the programming wand.The following results were noted (load resistor/reported diagnostics results, all values in ohms and battery status): (b)(4), with ifi yes (pcba was not reset).Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed.To check functionality of the pcba, the output parameters were programmed.An interrogation and system diagnostic test were performed, with a distance of one and one-quarter inches between the pulse generator and the programming wand.The following results were noted (load resistor/reported diagnostics results, all values in ohms and battery status): (b)(4), with ifi no.Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed.The pcba maintained as programmed, as observed on a bench oscilloscope.A comprehensive automated electrical evaluation showed that the pcba performed according to functional specifications; with the exception of the reed switch related tests (the foreign matter particle was not removed).The observed foreign matter particle may have been the contributing factor for the reported allegation of premature end of life.The pins 17 (p1.5/t a0) and 18 (p1.6/t a1) of a1 (microprocessor) were shorted together on a bench m106 pcba.The bench pcba was connected to a bench power supply and set to 3 volts.The ¿supply current wait¿ measured approximately 3.8ua.However, the bench pcba would not interrogate.This indicates that foreign matter particle (as found) did not create an electrical short between the pins 17 (p1.5/t a0) and 18 (p1.6/t a1) of a1 (microprocessor).Suspect that the flux under the foreign matter particle acted like an insulator, preventing an electrical short.In addition, the foreign matter located between the pins 17 (p1.5/t a0) and 18 (p1.6/t a1) of a1 (microprocessor), is suspected to have been a free floating particle, based on the bench pcba did not have a high current drain (required to cause the battery to swell) when the pins 17 (p1.5/t a0) and 18 (p1.6/t a1) of a1 (microprocessor) were shorted together.The origin of the foreign matter particle was not determined.Prior to settling between pins 17 and 18 of the microprocessor, it is likely that the metal particle was attached to a different area or component of the pcba, where it would have an adverse impact on current consumption, resulting in premature depletion of the battery.This is supported by the swollen condition and the low ¿as-received measured voltage of the battery.

• 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: 8754711
• MDR Text Key: 149839142
• Report Number: 1644487-2019-01264
• 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
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Model Number: 106
• Device Lot Number: 20213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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