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

Model Number 302-20

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Seizures (2063)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi#: (b)(4).

Event Description

It was reported by the physician that the patient's vns showed high impedance.Additionally, it was noted the patient recently had an increase in seizures, which was attributed to the high impedance observed.All of the output currents on the device were programmed off.The patient had x-rays performed; however, based on the images, the cause of the high impedance could not be determined.The patient was referred for vns replacement; however, no known surgical interventions have occurred to date.

Event Description

The patient underwent lead revision surgery on (b)(6) due to high impedance.It was noted the physician did attempt multiple pin re-insertions prior to replacing the lead, but the high impedance still existed.After the lead was replaced, the physician obtained good diagnostics of 2038 ohms, which was within normal limits.The explanted lead was received by the manufacturer for analysis.Product analysis is expected, but has not been completed to date.

Manufacturer Narrative

Brand name; corrected data, type of device; corrected data, model#, serial#, lot#, exp date; corrected data, device manufacture date; corrected data: this information was inadvertently left off of the supplemental #01 mfr.Report.

Event Description

Product analysis (pa) for the returned lead was completed.The reported high impedance was verified in the pa lab as a coil break was identified in the positive coil.Scanning electron microscopy images of the positive coil showed pitting or electro-etching conditions have occurred at the break location.Due to the pitting and metal dissolution, the fracture mechanism could not be determined on that specific coil end.Scanning electron microscopy images of the positive coil suspected broken mate-end suggested a stress-induced fracture.The allegation of the patient¿s increased seizures is beyond the scope of the pa lab; however, the confirmed high impedance may have been a contributing factor.It should also be noted that during the visual analysis of the lead, punctures and abrasions were observed on the inner silicon tubing of the lead.The abrasions and punctures appeared to be located at the same position as the coil break.Other than the previously mentioned coil break and typical wear and explant related observations, no other anomalies were identified in the returned portion of the lead.

Event Description

Product analysis was performed on the returned generator and found the first noted instance of high impedance was seen to have occurred on (b)(6) 2016.No other issues on the generator were seen.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6051453
• MDR Text Key: 58524832
• Report Number: 1644487-2016-02450
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 10/23/2019

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: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/01/2019
• Supplement Dates FDA Received: 12/06/2016; 12/14/2016; 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2005
• 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: 39 YR