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

Model Number 106

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

During the patient¿s initial implant surgery, it was reported that when turning the hex setscrew there were no torque clicks heard indicating a secure connection between the generator and lead.The surgeon reported turning the hex setscrew until the setscrew would no longer turn.The surgeon then proceeded to remove the hex setscrew and noted that the protective cover and o-ring seal had come out of the generator and remained inserted in the hex setscrew.It was noted that the detached component then fell to the ground.It was reported that the surgical technician had handed the generator to the surgeon with the hex setscrew already inserted in the generator prior to attempting pin insertion and securing.It was noted that another generator was used and the surgery was successfully completed.A review of the generator's device history records was performed and revealed that the generator passed quality control inspection prior to distribution.The device has been received by the manufacturer, but product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Generator analysis was completed on the returned generator.A cause could not be determined for the detachment of the septum plug as it was not returned for analysis, but the header septum cavity met the required specifications.Not being able to torque the setscrew was not duplicated in the product analysis (pa) lab with the generator and returned torque wrench.The torque wrench secured the bench setscrew onto the bench lead (that was inserted to the returned pulse generator header) (the returned torque wrench made audible clicks) and extracted the bench setscrew from the negative connector block of the returned pulse generator with no issues (lab conditions).The generator worksheet was received and there were no issues observed.In the data downloaded from the generator, it was noted that the prechange impedance was high on the date of surgery and the product was opened but not used, thus the high impedance does not indicate a device malfunction.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9535533
• MDR Text Key: 176547388
• Report Number: 1644487-2019-02530
• 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: 02/17/2020

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: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: 106
• Device Lot Number: 204641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2018
• 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: 43 YR