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

Model Number 304-20

Device Problems High impedance (1291); Output below Specifications (3004); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2016

Event Type  malfunction  

Event Description

It was reported by the physician's office that high impedance was observed with the patient's vns device.It was noted that due to the high impedance, the output current delivered to the patient was less than the intended programmed settings.It was later noted by the physician's office that x-rays were taken an came back negative.The patient was referred for surgery; however, no known surgeries have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported the patient had both his lead and generator replaced on (b)(6) 2016 due to high impedance.After the patient was replaced, his vns was checked and it was confirmed that his device was working as intended with an impedance value of 1939.It was later confirmed by the physician that the patient's pain over the generator site was due to the high impedance observed prior to the vns revision.The device is not expected to be returned as the explanting facility will not return to the manufacturer.

Manufacturer Narrative

This information was inadvertently left off of the initial mfr.Report.

Event Description

Clinic notes were received and it was noted the patient had voice alteration with stimulation; therefore, the settings were adjusted to try to resolve the voice alteration.The voice alteration appeared to begin at the same time as the high impedance occurred.Additionally, it was noted the patient was having a sharp pain over his generator periodically and sometimes with movement of his arm.

• 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: 5965755
• MDR Text Key: 55623540
• Report Number: 1644487-2016-02144
• 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,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2016; 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2011
• 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: 62 YR