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

Model Number 300-20

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 11/19/2018

Event Type  malfunction  

Event Description

The patient's generator and lead were explanted and returned for product analysis.The patient's lead was replaced due to incompatibility with the desired replacement generator.The lead was returned in three pieces and the portion of the lead including the electrode array was not returned for analysis, and therefore commentary cannot be made on that portion of the lead.An abraded opening was identified in the outer and inner tubing, which was likely the cause of the dried remnants of what appear to have once been body fluid inside of the outer and inner silicone tubing.With exception of the noted abraded opening, the condition of the returned lead portions is consistent with the conditions typically seen after explant procedure with no other anomalies noted.Product analysis was completed on the explanted generator.The generator was monitored for 24 hours in a simulated body temperature environment and the generator provided the expected level of output current for the entirety of the monitoring period.The generator performed according to functional specifications with no anomalies identified.No further 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: 8323320
• MDR Text Key: 135693216
• Report Number: 1644487-2019-00262
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2000
• Device Model Number: 300-20
• Device Lot Number: 17619C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Event Location: Other
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/1998
• 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: 57 YR