MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Detachment Of Device Component (1104); High impedance (1291)

Patient Problem Pain (1994)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

Clinic notes were received and indicated that the patient had experienced pain associated with stimulation.There was also a report of a settings adjustment which helped with the pain.The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015.However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system.Thus, the lead was replaced as well.It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached.No lead fractures were noted.It was unknown how the lead had become partially detached form the nerve.The diagnostics were normal following the generator and lead replacement.The explanted generator and lead were received by the manufacturer for analysis.However, analysis has not been completed to date.

Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the device evaluation.

Event Description

Analysis was completed on the patient's explanted generator.Analysis showed that the generator performed according to functional specifications.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.An analysis was performed on the returned lead portion.Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

Event Description

Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery.The pain began occurring following a settings increase.Thus, the settings were decreased which helped the pain.The pain was thought to perhaps have been caused by the detached electrode.No additional relevant information has been obtained to date.

• Brand Name: LEAD MODEL 302
• 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: 5002392
• MDR Text Key: 24231193
• Report Number: 1644487-2015-05462
• 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
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2005
• 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: 32 YR