MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Therapy Delivered to Incorrect Body Area (1508); Device Contamination with Body Fluid (2317); Appropriate Term/Code Not Available (3191)

Patient Problems Anxiety (2328); Depression (2361); No Code Available (3191)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

It was reported that a patient was experiencing hoarseness, though the device has been working well for him.Upon running a diagnostic, high lead impedance was also found.The device was disabled at this time.X-rays were performed and reviewed.Ap and lateral x-rays were available that displayed complete view of the neck and chest.Based on the images provided, the pin appeared to be fully inserted past the connector block.There were no obvious fractures or sharp angles in the images.A portion of the lead was routed behind the generator so it could not be assessed.Based on the images provided, there is no obvious cause for the high impedance; however the presence of microfractures cannot be ruled out.A follow-up with the physician clarified that the hoarseness was recent and did not bother the patient.No surgical intervention has occurred to date.No additional relevant information was received at this time.

Event Description

Clinic notes were received that stated that the device was disabled and the patient desired to keep the device off to see how he did without therapy.Over the course of the month, the patient's depressive symptoms worsened, including depressed mood, decreased interest in activities, poor energy, poor sleep, poor appetite, and poor concentration.The patient's anxiety worsened as well from concern over these symptoms.Plans have been made for lead revision.No surgical intervention has occurred to date.No additional relevant information was received at this time.

Event Description

The devices were returned for analysis, indicating that the full revision surgery occurred.It was indicated that the surgery was due to lead discontinuity.Surgeon's notes were attached providing the specifications of the generator and lead to be returned.Product analysis was completed on the returned generator.Visual examination of the device showed marking typical of surgical procedures.There was damage to the underside of the septum that we associated with loosing of the set screw during explant.The device output signal was monitored for more than 24 hours in a simulated body temperature environment, and the results showed no signs of variation in the output signal.Results of the tests showed no signs of variation in output signal and demonstrated that the device functioned as intended and according to functional specifications.No abnormal performance or any other type of adverse condition was found.Product analysis for the lead has not been completed to date.No additional relevant information has been received to date.

Event Description

Product analysis was completed and approved for the returned lead.The lead assembly was returned in two pieces.The electrodes were not returned for evaluation.For the first portion of the returned lead, setscrew marks were seen on the pin providing evidence of proper contact between the setscrew and pin at least once.The connector ring also had scratches most likely related to the canted spring in the generator header.The lead connector boot has partial detachment at the ring interface for an unknown reason.An abrasion was noted on the connector boot.Abraded openings were observed in both inner and outer silicone tubings.The end of the negative coil appeared to be cut and a coil break was identified at the end of the positive lead coil.The lead assembly had dried remnants of what appeared to have once been body fluids inside the inner and outer silicone tubing.For the second portion of the lead, abraded openings were found on both the inner and outer silicone tubings.The lead coils have kinks in at least one of the coils.A cut was noted toward the electrode bifurcation end, though no damage to the lead coils was noted at this point.Punctures were also observed.Abrasions were noted on the outer silicone tubing at multiple locations.The outer silicone tubing has a compressed appearance at multiple locations.The outer silicone tubing has what appear to be internal abrasions at multiple locations.Based on the appearance of the returned lead portions, it is believed that the identified kinks and punctured openings were most likely caused during the explant procedure.Scanning electron microscopy images showed that pitting occurred at the break location.However, due to metal dissolution, the fracture mechanism could not be ascertained.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 7095366
• MDR Text Key: 94513742
• Report Number: 1644487-2017-04936
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 02/09/2018; 07/19/2018; 08/16/2018
• Supplement Dates FDA Received: 03/05/2018; 08/13/2018; 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR