MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/26/2018

Event Type  malfunction  

Event Description

It was reported during a generator replacement surgery, that the replacement generator connected to the lead was displaying high impedance.High impedance was still observed after multiple attempts to reinsert the lead pin.A second accessory pack was opened for a different screwdriver, and the replacement generator was tested with the test resistor.Impedance was within normal limits and the device was functioning as intended.Upon unscrewing the test resistor, the set screw component fell out, though it was unclear if this was due to user error or the component being loose.A new replacement generator was connected to the lead with another third screwdriver, and diagnostics indicated impedance was within normal limits.Device history records were reviewed for the replacement generator and indicated that the device was sterilized and passed all quality inspections prior to distribution.The generator was returned for analysis, however no analysis has been completed to date.Further update from the company representative at the surgery indicated that the high impedance was found through both interrogations and multiple system diagnostics.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed for the returned generator.Visual examination performed revealed pieces of silicone rubber in the hex head of the setscrew and connector block and in lead pin cavity.Examination of the setscrew showed that the top of the hex head was damaged and rounded out.The bottom of the setscrew also revealed marks on the bottom from being secured on a lead, indicating multiple tightening on a lead pin or test resistor during the implant procedure.The septum was not returned, but the septum cavity was within specification.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Electrical test results showed that the pulse generator performed according to functional specifications.Test leads were inserted completely past the negative and positive connector blocks and were secured with a bench setscrew.The reported high impedance was not duplicated.It was noted that the reported inability to fully insert the lead was possibly caused by the silicone rubber debris in the lead cavity and in the hex head of the setscrew.It was noted that both torque wrenches tightened and released as expected with bench setscrew and test resistor.No further relevant information was received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• 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: 7456217
• MDR Text Key: 106407341
• Report Number: 1644487-2018-00648
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2019
• Device Model Number: 1000
• Device Lot Number: 204375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Operating Room
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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: 78 YR