MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Muscle Spasm(s) (1966)

Event Date 04/19/2018

Event Type  Injury  

Event Description

It was reported that during a new implant surgery, the surgeon had difficulties locating the vagus nerve.After placing the electrodes on a nerve, diagnostics were run and the surgeon noticed that the muscles in the patient's throat moved with stimulation, so he realized that he had placed the electrodes on the incorrect nerve.The surgeon attempted to locate the correct nerve, but he nor the resident or anesthesiologist could do so successfully due to the patient's anatomy.The devices were explanted, and the case was aborted.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 7528104
• MDR Text Key: 108724290
• Report Number: 1644487-2018-00817
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 42 YR