MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 01/29/2016

Event Type  Injury  

Event Description

The patient was intended to undergo a full vns replacement surgery.In the process of cutting the existing lead for removal, the surgeon nicked the patient's thoracic duct.The duct was repaired intraoperatively, but the implant of the lead was postponed.The new generator was opened prior to this injury, and was implanted in the procedure without a connecting lead.The implanted generator reportedly did not leave the sterile field.The packaging of the intended lead was not disrupted.The explanted lead and generator were disposed following surgery.Additional surgery or interventions have not occurred to date.No additional information has been received to date.

Event Description

It was reported that the patient's lead implant procedure to finalize the full vns replacement process was completed on (b)(6) 2016.Impedance on the full vns system was within normal limits at 1908 ohms.No additional pertinent information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5441425
• MDR Text Key: 38340403
• Report Number: 1644487-2016-00295
• 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: 01/29/2016

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: Health Professional
• Device Expiration Date: 09/30/2001
• Device Model Number: 300-20
• Device Lot Number: 27733C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/1999
• 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): Required Intervention
• Patient Age: 61 YR