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

Model Number 106

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

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

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).

Event Description

It was reported that during an implant surgery on (b)(6) 2016, the surgeon found a suspected device malfunction.It was reported that when inserting the screw driver into the silicon housing, the silicon became detached from the generator.The surgeon then discarded this generator and used a new device instead.No patient adverse event was reported.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.The return of the suspected device is expected but it has not been received to date.

Event Description

The suspected generator was returned to the manufacturer on 09/26/2016.An analysis was completed on the returned generator and the reported allegation of "detachment of component(s) septum plug" was not observed in the product analysis lab.The header septum cavity meets specification.The returned septum meets specification.However, the septum was damaged on the underneath side, suggesting that the setscrew was extracted up into the septum.This may be the contributing factor for allegation of "detachment of component(s) septum plug".The pulse generator performed according to functional specifications.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery showed an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 1.828% of the battery had been consumed.There were no performance or any other type of adverse condition found with the pulse generator.

Event Description

Additional information was provided indicating that the reason the physician had unscrewed the septum to the point of it popping out was due to difficulties he was having inserting the lead pin into the generator header block.The surgeon was reportedly having issues fully inserting the lead, so he kept unscrewing the septum plug until it came out.

Event Description

During a preliminary investigation initiated to study field complaints related to insertion difficulties reported during vns implant surgery, it was determined that the dimensions of the lead connector are critical to ease of insertion into the generator header during implant.Any measurement closer to the maximum assembly specification may cause insertion difficulty.It was also determined that the lead assembly document used at a secondary facility allowed for the lubrication of the lead connector with di water or the manufacturer's treated water in cases of excessive insertion force during functional tests, a practice not common to assembly at the main manufacturing facility.No additional 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: 5959327
• MDR Text Key: 55423641
• Report Number: 1644487-2016-02116
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,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: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 106
• Device Lot Number: 4299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/22/2018
• Supplement Dates FDA Received: 10/17/2016; 02/21/2017; 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2015
• 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