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

Model Number 105

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/01/2016

Event Type  malfunction  

Event Description

A patient's mother reported that her daughter had experienced a recent increase in seizures.The vns generator was reportedly low.The patient had reportedly received efficacy from vns but the seizures eventually got worse.A battery life calculation was performed using the known settings and showed that the generator was suspected to have battery life remaining.The patient's physician performed diagnostics which were reportedly normal.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

A device evaluation is not needed for this event because the physician has stated that he does not suspect the increased seizures are related to vns.

Event Description

Follow-up with the patient's physician verified that the physician did not suspect the patient's increased seizures were related to vns.The patient's surgery they were referred for was prophylactic.

Event Description

The patient underwent a generator replacement surgery due to prophylactic generator replacement.The explanted generator was reportedly discarded after the explant.

• Brand Name: PULSE GEN MODEL 105
• 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: 6123945
• MDR Text Key: 61022753
• Report Number: 1644487-2016-02722
• 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,Followup
• Report Date: 01/10/2017

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: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 105
• Device Lot Number: 4019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2016; 01/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 28 YR