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

Model Number 302-20

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/22/2014

Event Type  Injury  

Event Description

It was reported that during prophylactic generator replacement the surgeon pulled too hard on the generator and broke the lead.Pre-operative device diagnostics were within normal limits.The surgeon did not want to replace the lead at that time so the lead was cut and the surgery was completed.Lead reimplant is planned, but has not occurred to date.It was reported that the explanted lead and generator were discarded during there surgery; therefore, no product analysis can be performed.

Manufacturer Narrative

Event Description

Additional information was received that vns patient underwent implant surgery on (b)(6) 2016.It was reported that during the surgery, the electrode portion previously left in patient was totally removed from the vagus nerve.A new lead and generator were implanted; the lead impedance of the new vns system was ok.

• 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: 4255665
• MDR Text Key: 5016209
• Report Number: 1644487-2014-03037
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2008
• 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 Outcome(s): Other
• Patient Age: 43 YR