MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-30

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 02/20/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was seen at a routine post-op appointment.The patient had a recent generator replacement on (b)(6) 2018.The pa stated x-rays were taken to check the leads and they appear fine.The patient had surgery on (b)(6) 2018.Pin insertion was attempted but unsuccessful as high impedance still showed.The test resistor connected with the generator showed normal impedance therefore the lead was replaced which resolved the issue.The explanted lead has not been received for analysis to date.No additional or relevant information has been received to date.

Event Description

The explanted lead was received for analysis.Product analysis on the lead was completed and approved.An analysis was performed on the returned lead portion and the reported allegations of lead fracture were confirmed.Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the end of the connector pin quadfilar coil appeared to be broken approximately 122 mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface.It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes.With the exception of the discontinuity and abraded openings, the condition of the returned lead portion is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.No additional or relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7343004
• MDR Text Key: 102584104
• Report Number: 1644487-2018-00405
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 04/30/2010
• Device Model Number: 302-30
• Device Lot Number: 200476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2007
• 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