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

Model Number 300-20

Device Problems Fracture (1260); Device Abrasion From Instrument Or Another Object (1387); Naturally Worn (2988)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient underwent a generator replacement due to neos=yes on (b)(6) 2016.The patient's lead was replaced the same day for compatibility reasons.Prior to replacement surgery, system diagnostics confirmed system function.After surgery, two lead portions were received by the manufacturer for product analysis, however the electrode array was not included.The patient's lead was found to be fractured within the tubing and in the same area an abrasion in the outer and inner tubing was found.The abrasion was believed to be due to wear.Fluid was found within the lead inner tubing and this was attributed to the brasion.Regarding the lead fracture, two strands of the lead were fractured due to wear, the final strand of the lead was fractured due to rotational stress that likely occurred during product analysis continuity checks.Trauma or manipulation to the site of the abrasion and fracture was denied.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: 6097141
• MDR Text Key: 60092430
• Report Number: 1644487-2016-02593
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/17/2016

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: 01/31/2001
• Device Model Number: 300-20
• Device Lot Number: 19067C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/1998
• 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