MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Device Contamination with Body Fluid (2317); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2005

Event Type  malfunction  

Event Description

It was reported that the patient had not benefitted from vns and had their device explanted.Explanted products were returned for product analysis.Product analysis was completed on the lead.Continuity checks of the returned lead portion were performed during the functional analysis, and no discontinuities were identified.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Based on the findings in the product analysis lab, other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Abrasions were noted in multiple locations, and the lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes.This was noted to possibly be due to wear.

• Brand Name: LEAD MODEL 302
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14240306
• MDR Text Key: 290373219
• Report Number: 1644487-2022-00487
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2022

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: 06/16/2008
• Device Model Number: 302-20
• Device Lot Number: 1142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Event Location: Other
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2005
• 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: 52 YR
• Patient Sex: Female