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

Model Number 304-20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a company representative that during an initial implant the lead was not used by the surgeon as the metal became detached from the helix on the positive coil.When the surgeon used a new lead, there were no further issues.Review of the device manufacturing records revealed that the device met specifications prior to distribution.The product has been received for analysis which is underway, but has not been completed to-date.

Event Description

Analysis was completed on the returned lead portion 06/17/2016.During visual analysis the white electrode ribbon appeared to be stretched and mangled.The helical was misshaped and the suture partially detached.Imprints found on the inside groove of the helical were most likely made by the suture as a result of the manufacturing process.It appeared the ribbon and suture had been pulled out of the helical.The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure; however the absence of setscrew marks on the connector pin is evidence that the lead assembly was not fully implanted.The stretched ribbons and misshaped helices were most likely caused while attempting to place the electrodes on the vagus nerve.The sutures on the electrode helices appear to be intact.No obvious anomalies were noted.The lead was returned intact.Results of the overall dimensional and resistance measurements show that those parameters are within specification per the manufacturing assembly documentation.The condition of helical electrodes suggest extensive manipulation, leading to a misshaped helical section, and appears to be a user-related issue.

• 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: 5702908
• MDR Text Key: 48011972
• Report Number: 1644487-2016-01271
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2019
• Device Model Number: 304-20
• Device Lot Number: 203363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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: 52 YR