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

Model Number 106

Device Problems High impedance (1291); Detachment of Device or Device Component (2907)

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

Event Date 08/14/2018

Event Type  malfunction  

Event Description

It was reported that the diagnostics at the time of implant were normal.The patient's device was interrogated a month after implant and impedance came back has high.X-rays were conducted an no fractures were visible.The pin was possibly not fully in place however it was difficult to visualize through the x-ray.The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached.It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant.The surgeon removed the generator and replaced the silicone cover and placed the generator back in.The device was tested and normal impedances were seen.After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance.And low output current delivered.The patient was taken back in to surgery and it was seen that the lead was again not fully inserted.A new generator was implanted and high impedance was still seen, therefore the lead was revised.The set screw being undone and the detachment of the septum plug is reported.The high impedance suspected to be due to the lead is reported in mfr.Report # 1644487-2018-02262.The explanted generator has not been received to date.

Event Description

The explanted devices were received.The reported allegation of ¿high impedance¿ was not duplicated in the lab.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The reported allegation of ¿pin not fully inserted¿ was not duplicated in the lab.The in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area, passed.A bench lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).The reported allegation of ¿detachment of component(s) septum plug¿ was not observed (as received prior to decontamination) in the lab.The returned septum meets specification requirements and the pulse generator header septum cavity meets specification requirements.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.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.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead and the high impedance due to the lead is reported in mfr.# 1644487-2018-02262.

• 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: 8242712
• MDR Text Key: 133057024
• Report Number: 1644487-2019-00063
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

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: 01/15/2020
• Device Model Number: 106
• Device Lot Number: 5587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 69 YR