MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 04/25/2016

Event Type  malfunction  

Event Description

It was reported that during generator replacement the lead showed uninsulated spot just after the connection to the generator.Furthermore, the lead was bent 180 degrees at this spot.The lead was disconnected from the old generator with some difficulties.Then, it was plugged in the new generator.The lead impedance at this time was 1400 ohms.Generator was placed into the pocket, and the wound was closed.System diagnostics was performed again and it showed impedance below 600 ohms.New generator has been left in place.Follow up indicated that no explanted generator return is possible as this was discarded after the replacement surgery.It was also reported that the physician did not suspect a lead manipulation.The device manufacturing records were reviewed.The review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Further follow up with nurse indicated that the patient underwent a lead and generator replacement; during the lead replacement on (b)(6) 2016 no hex screwdriver was available in the or to disconnect the lead from the generator.That was the reason of the replacement of the generator as well.The facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

• Brand Name: LEAD MODEL 303
• 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: 5673038
• MDR Text Key: 46863241
• Report Number: 1644487-2016-00997
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 303-20
• Device Lot Number: 202226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• 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: 18 YR