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

Model Number 106

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

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

Event Date 09/12/2018

Event Type  malfunction  

Event Description

It was reported a company representative, that a generator immediately did not look right to the surgeon after being taken out of the packaging for an implant surgery.The septum plug looked frayed and did not look right initially the surgeon could not get the lead to go past the first connector block, but eventually he was able to use the hex screw driver to get the lead in.Then the lead pin tip would not go past the second connector block.The surgeon indicated that the generator and lead connection didn't look right.Impedance was ok at 2030 ohms but they had hesitations about using the generator.The surgeon had reportedly done many surgeries in the past.It was noted that he had tried irrigating the lead cavity.The attending company representative indicated that the surgeon probably tried to use the hexscrew 20 times.The surgeon decided to use a new generator.The manufacturer's device history records of the suspect generator were reviewed.The generator passed final quality and functional specification prior to release.The suspect product was received but product analysis on it has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The septum was cored and the setscrew showed mechanical wear at the socket, suggesting numerous insertions with a torque wrench.In addition, the septum showed damage on the underneath side, which indicates that the setscrew was extracted up into the septum.The reported allegation of ¿insertion difficulties¿, was duplicated in the pa lab, due to the debris (septum plug material and possible adhesive) in the header lead cavity.The in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area, passed.However, a bench lead inserted into the pulse generator header, would not go past the negative connector block (lab conditions), due to septum plug debris and possible adhesive debris in the header lead cavity.Eventually, the septum and possible adhesive debris was compacted enough that the bench lead pin barely past the negative connector block (lab conditions).Note that the septum plug debris may have resulted from multiple insertion attempts where the septum plug was cored it is unclear how the possible adhesive was found to be in the cavity in that is unknown if that material was left over from the manufacturing process or it was loosened and then dislodged during the insertion attempts.Other than the visual anomalies observed, there were no additional performance or any other type of adverse conditions found with the pulse generator.The generator passed functional specifications per the final electrical test.Note that product analysis is unable to assess the conditions of generators out of the packaging after they have been used.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7939457
• MDR Text Key: 123409760
• Report Number: 1644487-2018-01778
• 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: 11/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: 106
• Device Lot Number: 5658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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