MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/15/2018

Event Type  malfunction  

Event Description

It was reported by a company representative that during an implant surgery, diagnostics were performed and high impedance was observed.The physician made an attempt to remove, and re-insert the lead.The set screw was loosened and the physician tried to remove the hex wrench, but when doing so the septum plug popped out.The physician tried to re-insert it but was unable to.A new generator was used and was connected to the lead.System diagnostics with the second generator were within normal limits.Review of the manufacturing records for the generator verified the device met specifications prior to distribution.Additional relevant information has not been received to-date.The device was received by the manufacturer.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Debris from the septum was seen inside of the set screw, indicating the set screw had been backed off into the septum.This could lead to insufficient tightening of the set screw with the torque wrench, and may have been a contributing factor for the ¿pin not fully inserted¿ condition.The report of the detached septum plug, could not be evaluated as the septum plug was not returned.The header septum cavity met the device specification.Electrical evaluation showed that the device performed according to functional specifications.The battery measured 3.017 volts and did not show a depleted battery condition.The downloaded data revealed that 0.564% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 106
• 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: 7338071
• MDR Text Key: 102360326
• Report Number: 1644487-2018-00371
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 04/19/2018

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: 10/26/2019
• Device Model Number: 106
• Device Lot Number: 204298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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: 11 YR