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

Device Problem Malposition of Device (2616)

Patient Problem Seizures (2063)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

Xrays images were sent to the manufacturer by medical professional for review.Review of the images showed that the generator appears to be low in the chest, just above the diaphragm, in an abnormal placement.The filter feed-through wires appeared to be intact.The lead connector pin appeared to be fully inserted into the generator connector block.The electrodes appeared not to be placed in normal arrangement.The anchor tether seemed not to be fixed on the vagus nerve and the anode seemed to be partially dislocated from the nerve.No strain-relief loop and no strain-relief bend were found for the implant of the lead.Two tie-downs were used but their placement is not as recommended in the labeling.It could not be assessed from the images if a part of the lead is behind the generator.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Further information was received from the physician that the reason xrays were taken is they could not communicate with the generator.It was reported that the generator was not implanted auxilliary.It was reported that the vns patient felt following a strong seizure.The generator has dropped from its original location, and is in a lower location in the patient's body which is the suspected cause of the inability to interrogate the generator.

Event Description

Additional information received that patient underwent surgery.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 6036347
• MDR Text Key: 57930459
• Report Number: 1644487-2016-02394
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/08/2016
• 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 Age: 45 YR