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

Model Number 302-20

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 11/02/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 the patient had full replacement surgery.The implant card received states that the lead was also replaced for lead discontinuity.It was stated that during surgery the lead appeared to be tethered.The surgeon could tell it did not look right, that it seemed tight so he made the call to replace the lead.The site explanted the lead after surgery.

Event Description

Product analysis for the generator was completed and approved on (b)(6) 2015.The generator battery was confirmed to be depleted due to normal current consumption.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The device performed according to functional specifications.

• 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: 5289083
• MDR Text Key: 33962346
• Report Number: 1644487-2015-06697
• 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
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2010
• Device Model Number: 302-20
• Device Lot Number: 2567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2007
• 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 Age: 14 YR