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

Model Number 302-20

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

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

Event Date 08/28/2017

Event Type  malfunction  

Event Description

A system diagnostic test revealed high impedance on a patient's device.The following day, the patient underwent lead and generator replacement surgery, and preoperative diagnostic testing also showed high impedance.During the surgery, the physician confirmed that the lead pin had been fully inserted into the generator, leading him to believe that a lead fracture was the cause of the high impedance.The explanted lead was returned to 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.The lead was returned in two portions; however, the lead electrodes were not returned for evaluation so an assessment could not be made on that portion of the lead.Two pairs of set screw marks were observed on the connector pin, providing evidence that proper contact between the set screws twice.A single set screw indentation was observed at the end tip of the connector pin suggesting that the lead connector pin was not inserted completely at one point.An abrasion was also observed on the connector boot, and several abraded openings were observed on the outer and inner tubing in multiple locations.A coil break was also identified, and microscopy suggested that a stress-induced fracture occurred in the negative coil.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: 6888355
• MDR Text Key: 89359838
• Report Number: 1644487-2017-04501
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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: 69 YR