MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported by a vns patient's caregiver that the patient had atrial fibrillation and received cardioversion for the atrial fibrillation (b)(6) 2016 which was successful, however the procedure was reported to have caused his vns therapy to stop working.The vns was reported to have reduced the frequency and severity of the patient's seizures, however the seizure frequency and severity were reported to have increased since the vns stopped working.After surgical consult, generator replacement surgery was scheduled as the device was found to be at near end-of service.Lead impedance was reportedly okay after diagnostics.The device was interrogated and the output current was 1.5ma and had not been found to be disabled.No known surgery has occurred to-date.Additional relevant information has not been received to-date.

Event Description

Generator replacement surgery occurred on (b)(6) 2016.The explanted device has not been received by the manufacturer to-date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5577796
• MDR Text Key: 42685059
• Report Number: 1644487-2016-00803
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Model Number: 103
• Device Lot Number: 2163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR