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

Model Number 303-20

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2016, the physician was unable to insert the lead pin into the generator.There was no visible obstruction in the header and the set screw was out of the path.The setscrew was loosened and the hex screwdriver was used to try and release any air pressure in the header.However, troubleshooting failed to solve the problem.A new generator was used during the same surgery with the same, new lead, and the physician was able to insert the lead pin with no issues.Device manufacturing records were reviewed and indicated that there were no nonconformance issues identified before distribution.No additional relevant information has been received to date.The generator has been received by the manufacturer, but the analysis has not been completed to date.

Event Description

Analysis was performed on the returned suspect generator.The generator's setscrew was not returned.During analysis, no obstructions were observed in the pulse generator header lead cavity or the connector blocks.A bench in-line lead was able to be fully inserted into the generator past the negative connector block.The generator header lead cavity was confirmed to meet specification requirements.The septum was cored and damaged on the underneath side.This suggests that the setscrew was extracted up into the septum during explant.No anomalies were found.No additional relevant information has been received to date.

Event Description

An internal investigation of pin insertion difficulties identified that if any lead's large o-ring boot diameter was closer to the assembly specification of 0.135 in max, it may cause insertion difficulty.Although the lead's large o-ring diameter is not known, it is probable that this caused or contributed to the insertion difficulties occurred, since multiple troubleshooting steps to resolve the problem were performed.The device history records of the lead were reviewed.The lead passed final quality and functional specifications.No further relevant information has been received to date.

• 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: 6046818
• MDR Text Key: 58507402
• Report Number: 1644487-2016-02414
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

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: 08/17/2019
• Device Model Number: 303-20
• Device Lot Number: 203487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; 01/22/2018
• Supplement Dates FDA Received: 11/12/2016; 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 13 YR