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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problems Pain (1994); Seizures (2063); No Code Available (3191)

Event Date 01/26/2017

Event Type  malfunction  

Event Description

It was reported that a patient's device had high impedance.The patient recently began experiencing painful stimulation and an increase in seizures.The patient was scheduled to undergo a full revision surgery due to high impedance.It was also reported that the patient experienced coughing with increases in stimulation, but it is unclear whether the coughing had always occurred with stimulation or began with high impedance.The patient's increased seizures were occurring approximately once a month.X-rays were reviewed for the patient.It was difficult to assess whether the lead pins were both fully inserted inside the connector blocks due to the angle of the images provided; however, it appeared that neither of the two lead pins were fully inserted inside the connector blocks.Additionally, it could not be determined whether the feedthrough wires appeared intact.No gross fractures were observed, and no sharp angles in the lead were identified.The presence of a microfracture and/or lead discontinuity could not be ruled out.The patient¿s high impedance was likely due to incomplete pin insertion of both of the lead pins.Programming history was also reviewed, but there were no diagnostic results available.No additional information has been provided to date.No known surgical intervention has taken place to date.

Event Description

It was reported that high impedance was observed on the patient's device during surgery.A kink in the patient's lead was believed to be the cause of the high impedance, but the high impedance did not resolve when the lead was straightened out.The surgeon decided to proceed with a full revision.It was reported that the patient's increase in seizures was above his pre-vns baseline.The patient was reportedly experiencing painful stimulation in his left neck and shoulder, and the coughing that occurred with settings increases was not seen prior to the high impedance.The lead was discarded by the hospital, and the generator has been received; however, analysis on the generator has not been approved to date.No further information has been provided to date.

Event Description

Analysis was approved for the generator.Visual examination did not identify any anomalies with the generator.In its as received condition, the generator communicated normally.During the analysis, there was no indication from the device that an end of service condition existed.The device performed according to functional specifications.Product analysis did not confirm the end of service allegation and concluded that there was no abnormal performance or other adverse condition with the generator.No additional relevant information has been provided to date.

• Brand Name: 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: 6347523
• MDR Text Key: 67928424
• Report Number: 1644487-2017-03229
• 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: 04/28/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2000
• Device Model Number: 300-20
• Device Lot Number: 15395C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• 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): Other
• Patient Age: 33 YR