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

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 01/07/2019

Event Type  malfunction  

Event Description

X-rays were received of the patient's lead and it was stated that the patient's physician observed frays in the lead near the coil.X-rays were reviewed.Based on the scope of the image, the generator was not visible, so placement could not be determined as well as if the feed thru wires were intact, if the connector pin was fully inserted, if the lead was behind the generator, and if the lead wires were intact at the connector pins.The strain relief bend and loop were present, but were not per labeling as the loop was before the tie downs and appears to be too close to the bifurcation.A tie down could be visualized, but was not placed according to labeling.The lead was assessed and found to be a fracture of the lead.An item was also noted that something appears to have been wrapped around the electrodes which looks to be an unapproved material.Based on the x-rays received, the lead was found to be fractured before the coil.Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be assessed.No known surgical intervention has occurred to date.No other 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: 8264303
• MDR Text Key: 133854498
• Report Number: 1644487-2019-00108
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2003
• Device Model Number: 300-20
• Device Lot Number: 3027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2001
• 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
• Patient Age: 60 YR