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

Model Number 102

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/15/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had been experiencing an increase in seizure frequency and severity for the past month.One of the patient¿s seizures lasted for an extended amount of time and required the patient to visit the er.Clinic notes were received indicating that the cause of the patient¿s seizures was believed to be due to a low battery condition of the device.The patient¿s device was programmed to high settings and the patient often swiped his magnet.Follow-up revealed that the device showed the battery status was ok.No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the event.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description

It was reported that the patient underwent generator replacement surgery on (b)(6) 2015.The explanted device was discarded after surgery and will not be returned for analysis.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4494757
• MDR Text Key: 5328708
• Report Number: 1644487-2015-03783
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

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: 10/31/2010
• Device Model Number: 102
• Device Lot Number: 2258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2009
• 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: 56 YR