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

Model Number 302-30

Device Problem Disconnection (1171)

Patient Problem Neck Pain (2433)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

Clinic note dated (b)(6) 2015 note that the patient was undergoing surgery due neck pain at the left side of the neck.Surgical notes indicate that the surgery was unremarkable.It was reported that the patient did not have another vns system placed because the patient was "epilepsy free".The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the returned generator and lead was completed.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.There were no performance or any other type of adverse conditions found with the pulse generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description

Clinic notes were received dated (b)(6) 2015 that indicated that a patient implanted with a vns device has been experiencing pain at one of their lead "anchor" sites since he was last seen in (b)(6) 2014.The pain has persisted, the patient takes advil but is still able to complete daily activities.The patient was referred for surgery for "removal of the anchor." additional information was received that reported they were having their vns removed although unclear if whole device or just the anchor.Their pain is reported to be located in their neck and caused by a disconnected lead.It is unknown whether their was any trauma that caused the event.

• 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: 4588059
• MDR Text Key: 5604393
• Report Number: 1644487-2015-04110
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2015

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: 08/31/2010
• Device Model Number: 302-30
• Device Lot Number: 200593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/06/2015; 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2007
• 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: 22 YR