MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Difficult to Insert (1316); Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A physician reported to an international distributor that low lead impedance had been observed in a patient's vns system at a device follow-up.X-rays were taken and provided to the manufacturer for review.The x-rays showed no obvious anomalies but did reveal a possible sharp bend in the lead just above the generator and a possible pin insertion issue.The entire lead body could not be evaluated based on the x-ray images submitted.Submitted diagnostic data shows three low impedance (<600 ohms) measurements on (b)(6) 2016 along with 7 normal impedance measurements on that same date.A decrease in impedance is observed in the data over the last seven months.No patient adverse events have been reported.The physician intends to monitor the patient's condition and continue normal patient following.No specific intervention is planned and no surgical interventions have occurred to date.

Event Description

Follow-up on this event was provided indicating that the patient's impedance values were fluctuating.The patient had low impedance values that fluctuated to high impedance on (b)(6) 2016.Then, on (b)(6) 2016 the impedance values were all within normal limits.Then, the patient was visited on (b)(6) 2016 and the impedance values were high on multiple system diagnostic tests.The system diagnostic test on (b)(6) 2016 was also high.Then, the patient was seen on (b)(6) 2017 and the impedance was within normal limits.A new set of x-rays was provided for review and there was no indication of a sharp angle on this x-ray and the lead pin did not appear fully inserted into the connector block.No know surgical intervention has occurred to date.

Event Description

The patient was seen for a clinic visit on (b)(6) 2018, and high lead impedance was observed on her device.The distributor noted that the patient's device had previously shown both high and low lead impedance, but the impedance values had recently been within the normal range.Diagnostics performed at the clinic visit indicated an output current of only 0.50 ma was being delivered, although the generator was programmed to 1.5 ma.The distributor planned to send x-rays to the manufacturer for review.The x-rays were received by the manufacturer but have not been reviewed to date.The full programming history was reviewed for the patient's generator.Fluctuating impedance values were observed throughout a significant portion of the programming history, including the aforementioned low and high impedance, along with several internal impedance changes not observed in previous diagnostic tests.Low impedance was internally detected between multiple interrogations when impedance appeared to be normal in system diagnostic testing, indicating several quick fluctuations in impedance value.On (b)(6) 2017 impedance values were within the normal limits and remained so through multiple clinic visits until (b)(6) 2018; however, the high impedance was internally detected three days prior.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The x-ray images were reviewed by the manufacturer.Due to the angle of the generator in the image, lead pin insertion into the generator could not be assessed.The filter feedthrough wires appeared intact, and the lead wire appeared intact at the lead pins.The lead was observed in the neck and chest.Due to the exclusion of the patient¿s upper neck from the provided images, the presence of strain relief could not be assessed in its entirety; however, a strain relief bend did appear to be present, and a strain relief loop appeared to be complete.Two tie-downs secured the lead at the strain relief bend, and one tie-down secured the lead at the strain relief loop.A portion of the lead appeared to be routed behind the generator.No gross fractures or lead discontinuities were observed in the provided images as visibility of the lead was lost near the collarbone.3d-ct images were also included with the provided x-ray images.The presence and completeness of the lead strain relief was confirmed in the 3d-ct images.The portion of the lead routed behind the generator was also visible in the images, and a gross fracture was visualized in the portion of the lead that was not visible in the x-ray image.The thickness of the lead was minimal at the fracture location compared to the remainder of the lead body, signaling the potential for a short circuit condition to have existed.No additional relevant information has been received to date.No surgical intervention has occurred to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5672042
• MDR Text Key: 46723035
• Report Number: 1644487-2016-01091
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2018

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: 03/23/2019
• Device Model Number: 304-20
• Device Lot Number: 4293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided; 02/18/2018; 03/26/2018
• Supplement Dates FDA Received: 01/30/2017; 03/15/2018; 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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: 57 YR