MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

A patient underwent a full revision surgery for patient comfort due to a chronic neck pain.The neurologist was unsure if the pain was related to the device or not.The explanted devices were shipped back for analysis.Analysis was completed for the generator, indicating no apparent device malfunctions.The lead assembly was returned in four portions; the portion of the lead assembly including the electrodes and tie downs was not returned.Setscrew marks were observed on both connector pins, indicating good electrical connection existed at one point.Abraded openings were found on both the outer and inner silicone tubing in one of the return portions of the lead.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Other than the abraded tubing openings, no additional obvious anomalies were noted.It was concluded that the abraded openings were likely due to normal wear.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7912423
• MDR Text Key: 124012666
• Report Number: 1644487-2018-01703
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2003
• Device Model Number: 300-20
• Device Lot Number: 2836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Event Location: Other
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2001
• 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