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

Model Number 304-20

Device Problems Corroded (1131); High impedance (1291); Mechanical Problem (1384); Low impedance (2285)

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

Event Date 06/09/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on the patient's device.The physician considered programming the patient's device off but was not sure if she should because the patient still had good seizure control.The device history records of the generator and lead were reviewed, and both devices performed to specification prior to release.The physician decided to only decrease the patient's settings since the patient wasn't having any issues associated with the high impedance and was still seizure free.There was also no known cause of the high impedance, such as trauma.No surgical intervention has occurred to date.

Event Description

The patient was seen again, and low impedance was present on the patient's device.The patient's device was programmed off.No surgery has occurred to date.

Event Description

Lead revision surgery occurred.The explanted device has not been received by the manufacturer to-date.

Manufacturer Narrative

Event description, corrected data: it was inadvertently not provided on follow-up report#2 that the device had been received by the manufacturer.Device available for evaluation, corrected data: the date the device was received was inadvertently not provided on follow-up report#2.

Event Description

The explanted device was received by the manufacturer.Analysis was completed on the returned lead portions.Visual analysis identified broken coils approximately 1.5 mm from the electrode bifurcation.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting on one of the broken coil strands.The area on the remaining broken coil strands was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture which most likely completed the fracture.A flat spot was observed on the coil surface.The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.

• 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: 6685451
• MDR Text Key: 79030841
• Report Number: 1644487-2017-04092
• 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: 12/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2020
• Device Model Number: 304-20
• Device Lot Number: 203767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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: 6 YR