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

Model Number 304-20

Device Problem Fracture (1260)

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

It was reported that a patient needed a full revision.Further information was received indicating that the patient's device had high impedance.The patient had full revision surgery due to the high impedance.The explanted products have not been received to date.

Event Description

The explanted lead and generator were received, but analysis has not been approved to date.

Event Description

Analysis on the generator was approved.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead has not been approved to date.

Event Description

Analysis on the lead was approved.Note that a portions of the electrode inner silicone tubes and quadfilar coils and anchor tether were not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the outer silicone tubing appeared to be compressed and twisted.The twisted condition of the lead suggested some level of patient manipulation occurred during the implant life of the device.There were two lead breaks identified in the returned lead portion.Scanning electrode microscopy identified that both fractures were due to mechanical damage and had pitting present.One of the fractures was due to rotational forces, which caused a stress induced fracture.With the exception of the observed discontinuities, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portions were performed, and no other discontinuities were identified.

• 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: 6404916
• MDR Text Key: 69947486
• Report Number: 1644487-2017-03383
• 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,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Model Number: 304-20
• Device Lot Number: 2930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2011
• 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: 14 YR