MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced an unusual seizure during device settings adjustments; therefore, the physician left the settings as previously programmed.The patient reported that the seizure was different than what she was used to.Attempts to obtain additional relevant information have been unsuccessful to date.The relationship of the unusual seizure to vns is unknown.

Manufacturer Narrative

The previously submitted mdr inadvertently provided an incorrect event date.

Event Description

Information was received from the neurologist via a company representative on (b)(6) 2015.The date of onset of the new seizure type was (b)(6) 2015.The patient's seizures are less severe since vns.The new seizure type is not related to vns, but is related to external factors.No interventions were planned or taken.Diagnostic results were not reported.

Event Description

Further reports regarding this patient's increased seizures were received and this and all further relevant information regarding this event will be captured mfr.Report # 1644487-2017-03470.

• Brand Name: PULSE GEN MODEL 102
• 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: 4860270
• MDR Text Key: 22158322
• Report Number: 1644487-2015-04964
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2012
• Device Model Number: 102
• Device Lot Number: 2916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• 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: 59 YR