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

Model Number 300-20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Chest Pain (1776)

Event Date 05/01/2016

Event Type  Injury  

Event Description

It was reported that a patient went to the emergency department because she was experiencing continuous, painful stimulation in the left neck and chest since (b)(6) 2016.However, the patient's device had been programmed off 5 years prior and was not programmed back on.A magnet was placed over the device for 30 seconds but was removed again because the patient complained that it was painful with the magnet over the device.The patient was transferred to a different hospital, and the physician noted that the patient's normal and magnet mode output currents were programmed to 0ma and that the device had been disabled for quite a while.However, the patient was still in pain.The physician asked the patient if anything unusual had happened prior to the pain, and the patient said that nothing happened.Diagnostics were performed, but the results were not provided.The patient's devices were explanted on (b)(6) 2016 due to the pain.The explanted devices have not been received to date.Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Describe event, corrected data: initial report inadvertently reported that the devices had not been received to date.Device available for evaluation, corrected data: initial report inadvertently reported that the devices had not been received to date.

Event Description

The explanted generator and lead were received on (b)(6) 2016.Analysis has not been approved to date.

Event Description

The explanted generator and lead both underwent product analysis.An end-of-service warning message was verified for the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.An analysis was performed on the returned lead portions, but the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.There was an abraded opening in the inner tubing of the lead, but the cause could not be determined.Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.Additional information was received from the patient's explanting physician stating that the electrodes had been connected to the ansa cervialis instead of the vagus nerve.He believed this was the reason for the patient's reported neck pain.He also stated that the device never worked well for the patient, most likely because it was implanted on the incorrect structure.

• 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: 5685858
• MDR Text Key: 46165055
• Report Number: 1644487-2016-01153
• 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,Followup,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2003
• Device Model Number: 300-20
• Device Lot Number: 2802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2001
• 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: 23 YR