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

Model Number 302-30

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Seizures (2063); Discomfort (2330)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason.It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown.The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery.The reason for the protrusion is unknown.Device diagnostics were within normal limits.It was reported that the lead was replaced to preclude a serious injury and for patient comfort.The pain and protrusion resolved following generator and lead replacement surgery.The explanted lead was discarded during surgery.The explanted generator was returned for analysis on 02/10/2015.Analysis is underway, but has not been completed to date.No additional relevant information has been received to date.

Event Description

Analysis of the generator was completed on 03/05/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4570551
• MDR Text Key: 5472005
• Report Number: 1644487-2015-04043
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 302-30
• Device Lot Number: 200556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2007
• 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: 30 YR