MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

A patient underwent lead and generator replacement surgery due to a high impedance message observed during diagnostic testing of the device.The explanted lead and generator were returned to the manufacturer, but product analysis has not been completed to date.

Event Description

Analysis was approved for the generator.The generator communicated normally upon interrogation, and the device had not yet reached end of service.The generator performed according to functional specifications.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.Analysis was approved for the lead.A section of the lead assembly was returned for analysis in two pieces.The electrodes were not returned for evaluation so an assessment on that portion of the lead cannot be made.Three sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least twice.A single set screw indentation was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time.A lead break was observed in the positive coil of the lead past the electrode bifurcation.The tubing was also torn at this location.Microscopy was performed and identified pitting at the break location; however the fracture mechanism could not be identified.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 6912503
• MDR Text Key: 88110671
• Report Number: 1644487-2017-04538
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2005
• 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: 25 YR