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

Model Number 300-20

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 01/31/2000

Event Type  malfunction  

Event Description

The patient's vns system was explanted and returned to the manufacturer for product analysis.Product analysis of the lead identified abraded openings in both the outer and inner silicone tubing, and the dried remnants of what appeared to have once been body fluids were found within both the outer and inner tubing.There were no obvious points of entry for said body fluids apart from the abraded openings and the cut ends (likely made during the explant procedure).No other anomalies were identified with the returned lead portion.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9940844
• MDR Text Key: 188276338
• Report Number: 1644487-2020-00578
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

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: 12/28/2001
• Device Model Number: 300-20
• Device Lot Number: 30294C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Event Location: Other
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/1999
• 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: 39 YR