MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problems Headache (1880); Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 04/15/2016

Event Type  malfunction  

Event Description

It was reported that a patient was experiencing coughing, intense stimulation, headaches, and pain in his neck.System diagnostics showed that the device had high impedance.The patient was programmed off after the high impedance was found.X-rays were taken and reviewed by the manufacturer.The x-rays did not show any gross lead fractures that could have contributed to the high impedance.The lead pin did not appear fully inserted to the connector block.No surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient was sent to a speech pathology specialist and the medical professional has determined it is possible that the patient has a damaged vocal cord due to increased stimulation.The physician wants to see what will happen with the patient's recovery with the vns off.The patient feels that the device stimulation continues even though the device has been programmed off.It was reported that the patient desired explant of the vns and was scheduled for surgery.The patient underwent surgery on (b)(6) 2016; however, explant could not be confirmed.It was reported that the patient was also experiencing difficulty swallowing and that the patient had been followed by an ent.No additional relevant information has been received to date.

Event Description

It was reported that the explant occurred and the device was discarded by the explanting facility; therefore, no product analysis can be performed.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 5661432
• MDR Text Key: 46601348
• Report Number: 1644487-2016-00938
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 04/22/2016

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: 10/31/2007
• Device Model Number: 102
• Device Lot Number: 014865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/15/2016; 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2006
• 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: 60 YR