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

Model Number 103

Device Problem Battery Problem (2885)

Patient Problem Seizures (2063)

Event Date 10/01/2016

Event Type  Injury  

Event Description

It was reported from clinic notes dated (b)(6) 2016 that the patient had 2 seizures on the same day in (b)(6) 2016.The physician didn't see any obvious abnormalities to explain the seizures.They state that the vns has been implanted since 2010.The physician interrogated the device and found that the battery needs replacement.He changed her on time 60 sec to 30 sec to help prevent further seizures so it will fire more often.Notes also state that she mentioned a few times that she is having increased memory issues.The physician thinks this might be due to breakthrough partial complex seizures that are subclinical.The physician believes this will be corrected once the vns battery is changed.No diagnostics were provided.

Event Description

It was reported the patient underwent generator replacement surgery.It was reported the device would likely not be returned to the manufacturer.

• 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: 6149665
• MDR Text Key: 61592791
• Report Number: 1644487-2016-02805
• 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
• Report Date: 02/21/2017

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: 07/15/2011
• Device Model Number: 103
• Device Lot Number: 201228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• 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: 35 YR