MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Device Expiration Issue (1216)

Patient Problem Seizures (2063)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery on (b)(6) 2015 due to an increase in seizures, the vns patient¿s replacement generator was tested with the existing lead which showed normal device function and battery status.After the patient was closed, the device was tested again and showed an end of service condition.The patient was reopened and another generator was used for the procedure.Follow-up revealed that electrocautery was used for the subcutaneous tissue during the procedure while the generator was inside the generator pocket.There was no indication that electrocautery had contacted or damaged the generator upon removal.Gloves were worn throughout the surgery to prevent potential static discharge to the generator.The suspect generator has been returned to the manufacturer where analysis is currently underway.The increase in seizures event was reported in manufacturer report # 1644487-2014-03183.

Manufacturer Narrative

Event Description

Analysis of the returned generator was completed.Review of the downloaded data indicated that the pulse disabled byte was set to a value that represents a vbat

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4532198
• MDR Text Key: 17574061
• Report Number: 1644487-2015-03921
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 105
• Device Lot Number: 4024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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: 26 YR