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

Model Number 302-20

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

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

Event Date 11/16/2017

Event Type  malfunction  

Event Description

Clinic notes indicated that high impedance was observed on a patient's device.Although the device was programmed to deliver 2ma, diagnostic testing on the device indicated the device was only providing 1.5ma of normal mode output current.The generator was programmed off due to the high impedance, and the patient was referred for surgery.The patient underwent lead and generator replacement surgery.The explanted lead and generator have not been received by the manufacturer to date.

Event Description

The explanted lead and generator were received by the manufacturer for analysis, but analysis has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the lead.A portion of the lead, excluding the electrodes, was returned in one piece for analysis.Set screw marks were observed on the connector pin providing evidence that proper contact between the set screw and connector pin existed at least once.A coil break was identified is the positive lead coil.Microscopy identified pitting at the coil break, and flat surfaces were observed at the break locations.Abraded openings were observed along the inner and outer tubing of the lead, and body fluids were observed both layers of tubing.Other than the observed anomalies, no other anomalies were observed with the returned portions of the lead.Analysis was also approved for the generator.When received, the data was downloaded from the generator and reviewed.The last measured significant impedance change was observed on the date of explant.The impedance values prior to and after the point of change were both indicative of high impedance, confirming that high impedance was present for the system prior to explant surgery.No surface abnormalities were noted on this device.Diagnostics for the generator were within the normal limits for the programmed parameters.The generator performed according to functional specifications.There were no adverse issues identified with the returned generator.No additional 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: 7119407
• MDR Text Key: 94991753
• Report Number: 1644487-2017-05005
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

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: 03/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 12/15/2017; 01/15/2018
• Supplement Dates FDA Received: 01/08/2018; 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2005
• 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: 53 YR