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 04/06/2017

Event Type  malfunction  

Event Description

During a generator replacement surgery, the surgeon identified a small nick in the lead insulation next to the connector boot, but stated it did not appear to expose the metal of the lead wire.Diagnostics performed with the generator outside of the pocket were within normal limits.However, diagnostics with the generator inside the pocket showed high impedance.The generator was then removed from the pocket and multiple attempts to re-insert the lead pin verifying proper pin insertion each time did not resolve the high impedance.At this point, the surgeon stated the issue was with the lead and he would have to replace it at a later date.The replacement generator was implanted without replacing the lead.Additional relevant information has not been received to-date.No known surgery to replace the lead has occurred to-date.The explanted generator has not been received to-date.

Event Description

Lead revision surgery occurred.Pre-operative diagnostics results showed low impedance.The lead was cut near the generator and the attached lead was removed with the generator.The old coils and portion of the lead were left intact on the nerve.The explanted lead portion was discarded in the operating room (or).

• 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: 6546149
• MDR Text Key: 74474835
• Report Number: 1644487-2017-03721
• 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
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2005
• 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: 20 YR