MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Crack (1135); Fracture (1260); High impedance (1291)

Patient Problems Ecchymosis (1818); Seizures (2063); No Code Available (3191)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

It was reported that the patient was recently implanted.The device was initially programmed on two weeks ago during which there was a normal impedance reading.During their follow-up office visit, high impedance was obtained.It was stated that the patient had not had any injuries and is not known to be a picker or twiddler.The patient also reported to no longer be feeling stimulation.The patient has been referred for x-rays.Information was received indicating per the patient's mother, the patient fell and had bruising around the chest area.X-rays were taken and were found to not be beneficial.Patient has had consult for surgery.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Product analysis on the returned lead portion was performed.Note that a small portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the end of the connector ring quadfilar coil appeared to be twisted apart approximately 332mm and the end of the connector pin quadfilar coil appeared to be twisted apart approximately 339mm from the end of the connector boot.Scanning electron microscopy (sem) was performed on the end of the connector ring quadfilar coil (found at 332mm) and identified the area as having evidence of a stress induced fracture (rotational forces) with mechanical damage.Pitting and secondary break lines were observes on the coil surface.Sem was performed on the end of the connector pin quadfilar coil (found at 339mm) and identified the area on three of the coil strands as having evidence of a stress induced fracture (rotational forces) with mechanical damage.The area on the remaining coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture.It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.There were slice marks that appeared to have been made by a sharp object which could have been used during the explant procedure and dried remnants of what was once body fluid inside the outer silicone tubing with no obvious paths other than the cut ends from the explant procedure.There was also abrasion in various locations possibly caused by normal wear that did not penetrate the tubing.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations fracture of lead.Note that since a small portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description

Both the lead and generator were returned for product analysis.Product analysis of the generator was completed.Results of diagnostic testing indicated the device was operating properly and communicated properly.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Electrical test results showed that the pulse generator performed according to functional specifications.Review of the decoder indicated there was no note of a reset occurring.The high impedance was found to have began prior to the date it was found based on the data of the generator.There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative

Event description - correction - inadvertently did not include the review of the production records that was performed in the initial mdr report submitted.Method - correction - inadvertently did not code analysis of production records that was performed in initial mdr submitted.

Event Description

Implant card was received indicating the patient received a full revision.It was also reported that after the patient fell, there was an increase in seizures which is when the high impedance was found.It was stated by the or support specialist that the surgeon slightly tugged on the lead and it came out, appearing as though someone had cut the lead somehow.It was reported that the explanted product will be returned for product analysis but has not been received to date.A device history review was performed for the lead during which no issues/anomalies were found for the lead during the manufacturing process.

• Brand Name: LEAD MODEL 304
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8632018
• MDR Text Key: 145775675
• Report Number: 1644487-2019-00977
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2019

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: 01/07/2023
• Device Model Number: 304-20
• Device Lot Number: 204757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 07/30/2019; 09/05/2019
• Supplement Dates FDA Received: 07/17/2019; 08/23/2019; 09/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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: 9 YR