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

Model Number 106

Device Problems High impedance (1291); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

Patient Problems No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 10/01/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's generator.At the time of the patient's replacement surgery, a little over a month prior, impedance was within normal limits.Additionally, it was reported that a month after implant the patient's lead impedance was within normal limits.The patient's generator was disabled due to the high impedance detected.No relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient underwent replacement of their generator and lead due to high impedance.The suspect product has not been received to date.No further relevant information has been received to date.

Event Description

It was reported that during the lead revision surgery the surgeon attempted to re-insert the lead pin, but high impedance was still detected.It was additionally reported that no fracture of the lead was visualized and the company representative indicated that he thought there was a lot of fibrosis present.The suspect product has been received by the manufacturer and is pending product analysis.No further relevant information has been received to date.

Event Description

Clarification was received from the product analysis department regarding the coil break s.The cause of the coils reported to have a melted appearance was likely due to the coils being exposed to a high temperature device, such as a cauterizing tool, during the explant surgery.As for the coil break identified 23 mm from the electrode bifurcation with a rotational appearance, it was identified that this was likely caused by excessive manipulation of the coil at explant.Outside of the observed coil melted appearance, the condition of the returned lead portions and coils is consistent with conditions that typically exist following an explant procedure.The set of setscrew marks found near the end of the connector pin indicated that the lead had not been fully inserted into the cavity of the generator at one point, and the as received condition of the lead and generator suggest that the positive connection to the generator may have been suspect.Based on the findings in product analysis related to the condition of the lead, there is evidence to suggest incomplete pin insertion of the lead may have contributed to the reported high impedance.No further relevant information has been received to date.

Event Description

Product analysis on the returned generator was completed.Analysis of the generator concluded that there were no performance or any other type of adverse conditions found with the generator outside of the high impedance detected on the generator.Product analysis was completed on the returned portion of the lead.The lead was returned in 7 portions.An abraded opening was noted on the outer silicone tubing and provided a leakage path for dried remnants of what appeared to have once been body fluids inside of the outer tubing.There was a set of setscrew marks found near the end of the connector pin that indicated the lead was not fully inserted at one point in time.There was an additional set of setscrew marks that indicated that at one point there was a proper good mechanical connection showing the lead was fully inserted at some time.The end of the coils had a fatigue appearance, confirmed by scanning electron microscopy, which indicated that it was possible that the coils were exposed to a high temperature device, such as a cauterizing tool, during the explant of the lead.There was a coil break identified 23 mm from the electrode bifurcation with rotational appearance.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Based on the damaged condition of the returned lead, it is unclear whether a lead fracture may have contributed to the high impedance.No further 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: 8120494
• MDR Text Key: 128914854
• Report Number: 1644487-2018-02170
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2019
• Device Model Number: 106
• Device Lot Number: 204122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• 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
• Patient Age: 18 YR