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

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/01/2015

Event Type  Injury  

Event Description

It was reported that the patient was referred for generator replacement surgery.Information received at the time of the referral showed that the patient experienced tugging sensations from the lead when he turned his head to the right.Follow up with the referring physician's office determined that the patient was still experiencing these sensations, and the patient noticed it was exacerbated by wearing a seatbelt.Device diagnostics were confirmed to be within normal limits in the most recent appointment on (b)(6) 2016.The physician's office could not offer an assessment and deferred to the potential surgeon as a source of information.Surgical intervention has not occurred to date.Attempts for additional pertinent information have been unsuccessful to date.

Event Description

The office of the intended surgeon reported that the patient did not indicate whether or not there were pulling sensations when he was seen in (b)(6) of 2015.No interventions were planned for the lead at that time.No additional pertinent information has been received 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: 5771226
• MDR Text Key: 48819301
• Report Number: 1644487-2016-01512
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2006
• 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: 50 YR