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

Model Number 304-20

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

It was reported that the patient's device was interrogated and a low impedance warning was observed.X-rays were reviewed by the physician and there was no issues found on them.The x-rays have not been reviewed by the manufacturer to date.The patient is being referred for a surgical consultation due to the low impedance.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Event Description

X-rays were received and a review was performed.The cause of the low lead impedance could not be found.The visible portions of the lead were assessed and no fractures or discontinuities could be observed.There were portions of the lead that could not be seen so the entire lead could not be assessed.The patient's lead was replaced and the lead impedance was noted as ok after the replacement.After the explant, the lead was noted to look like the lead body had pulled away from the pin and it is unclear if this is the cause of the low impedance or if this was damage that occurred during the explant surgery.The lead has not been received by the manufacturer to date.

Manufacturer Narrative

Describe event or problem - corrected information: in supplemental report #01, it was stated that the device had not been received by the manufacturer to date however the device had been received at that point.Device available for evaluation - corrected information: supplemental report #01 needed to state the device had been returned to the manufacturer on 06/02/2017.Evaluation codes - corrected data: the conclusion coding in supplemental report #01 did not have code (b)(4) to indicate the device had been received and that evaluation was in progress.

Event Description

The lead was returned to the manufacturer and analysis was completed.The lead was returned in two portions which contained the lead pin and the electrodes.There were abrasions noted in the outer and inner tubing of the silicone most likely caused by wear.The connector boot wiring appeared to have been cut or torn at the end of the connector ring.This is most likely related to manipulation from the explant procedure.There was also melting of the wiring due to exposure to a high temperature device, most likely cautery during the explant procedure.The lead pin had a set screw mark which confirmed that it was fully inserted at one point in time.Continuity checks were performed on the returned lead portions and no discontinuities were identified.Analysis was unable to confirm the cause of the low impedance event.

• 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: 6546620
• MDR Text Key: 74478908
• Report Number: 1644487-2017-03724
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2017

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: 01/25/2019
• Device Model Number: 304-20
• Device Lot Number: 4222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017
• Supplement Dates FDA Received: 06/08/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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: 17 YR