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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problem Seizures (2063)

Event Date 12/22/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was identified on the patient¿s device.The patient had been having more violent behavior, which may have been sub-clinical seizures, for the previous three weeks.Swiping the magnet did seem to help with the violent behavior.No further relevant information has been received to date.

Manufacturer Narrative

Corrected data, explant date - the explant date was inadvertently omitted from the initial report.

Event Description

The patient had full revision surgery due to high impedance.The generator and lead were received, but analysis has not been approved to date.

Event Description

Analysis on the generator was approved.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified.The device output signal was monitored, and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis on the lead was also approved.Abraded openings were noted on the outer and the inner silicone tubing.A break was identified in the positive coil.Scanning electron microscopy images of the positive coil (including strand segments) shows that pitting or electro-etching conditions have occurred at the break location and at the discolored surface.Also, the positive coil show that a stress-induced fracture has occurred in at least two strands of the quadfilar coil.However, due to mechanical distortion (smoothed surfaces), surface contamination and/or metal dissolution the fracture mechanism on others strands cannot be ascertained.Scanning electron microscopy images of the negative coil verified that pitting or electro-etching conditions have occurred at the suspected area.Note that since a portion of the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.No other anomalies were identified in the returned lead portions.

• 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: 7262571
• MDR Text Key: 99954356
• Report Number: 1644487-2018-00197
• 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,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2006
• 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 Outcome(s): Other
• Patient Age: 31 YR