MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Mechanical Problem

Event Date 08/31/2017

Event Type  Malfunction  

Event Description

It was reported that the surgeon opened a lead package for a new patient implant and was concerned about the way the lead coils looked. The surgeon thought something was wrong with the lead coil and felt the lead coils were fractured in the package and thus did not use it. A different lead was successfully used for the surgery. A review of device history records for the lead shows that no unresolved non-conformances were found. Analysis is underway but has not been completed to date.

Event Description

The lead underwent product analysis and a kink in at least one of the lead coils was noted past the electrode bifurcation. The anchor tether was also visualized to be torn into two pieces and the suture partially detached from the helix. Suspected tool imprints were identified on the anchor tether silicone helix near the tear. Though difficult to state conclusively based on the inspection results it is believed that the most likely root cause for the anchor tether suture detachment and the observed damaged to the anchor tether helix was manipulation of the lead not consistent with our labeling. Other than the above mentioned observations and typical implant or explant related observations, no other anomalies were identified in the returned lead assembly.

• Brand Name: LEAD MODEL 304
• 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: 6922020
• Report Number: 1644487-2017-04540
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/06/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 304-20
• Device LOT Number: 204071
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial