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

Model Number 102

Device Problem Battery Problem (2885)

Patient Problem Seizures, Grand-Mal (2168)

Event Date 03/01/2016

Event Type  Injury  

Event Description

Clinic notes were received for a replacement referral.The notes indicated the vns was checked by a company representative and will need the battery changed.In notes dated (b)(6) 2016 the patient was experiencing several tonic-clonic seizures and was admitted to the hospital.It was stated the vns initially helped but over the past years hasn't been helping much.An estimate of battery life calculation using data available in the manufacturer's in-house programming history database revealed 1.9 years until near end-of-service.Additional relevant information has not been received to-date.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: "hospitalization" was inadvertently not marked on the initial report.

Event Description

Follow-up to the provider's office on (b)(6) 2016 revealed that the battery was noted to need replacement, but stated the specific battery status indicator was not present in the notes.The increase in seizures was attributed to the battery needing to be changed.It was clarified that the device was working for the patient before, but had not been adjusted since (b)(6) 2015 and needed to be adjusted.No known surgery has occurred to-date.

Event Description

Generator replacement surgery occurred.The explanted device has not been received by the manufacturer to-date.

• 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: 5905694
• MDR Text Key: 53075093
• Report Number: 1644487-2016-01922
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: 102
• Device Lot Number: 201936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2016; 10/03/2016; 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR