MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Device Operational Issue (2914); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2007

Event Type  Injury  

Event Description

It was reported on 08/11/2016 that the patient has been implanted since 2006 and received therapy until she felt that she was having an increase in seizures associated with stimulation and as a result had her vns device disabled.The patient saw another physician who saw that with the device disabled the patient continued to have seizures so he re-enabled the device at its lowest settings and saw that the device is at neos-yes.The programming history database was reviewed on 08/22/2016 for the m102 generator.History was available from date of implant (b)(6) 2006 through (adjusted date) (b)(6) 2015.It appears that the date of device disablement mentioned in this file was (b)(6) 2007 and there is no history suggesting the device was programmed back on as of (b)(6) 2015.Follow-up showed that the physician cannot confirm or deny the disablement date because he does not have those records.The physician that the patient still has not seen efficacy since it has been turned back on.To the best of his knowledge, the seizure increase was above baseline although he does not have the old records to confirm.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5921553
• MDR Text Key: 53719284
• Report Number: 1644487-2016-01972
• 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
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2008
• Device Model Number: 102
• Device Lot Number: 015168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2006
• 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: 22 YR