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

Model Number 103

Device Problem Device Expiration Issue (1216)

Patient Problem Seizures (2063)

Event Date 11/01/2015

Event Type  Injury  

Event Description

Intiially, it was reported that the patient was referred for generator replacement due to eri - yes.Clinic notes dated (b)(6) 2015 note that the patient thinks he is having more seizures.It was noted that he thinks that the generalized seizures have been a little bit more frequent.It was noted that the vns generator is at end of service and that may be a possibility of why the seizures are worse.The physician noted that generator replacement will help.No additional relevant information has been received to date.No known surgical interventions have been performed to date.

Event Description

The physician's office reported that the increased seizures are attributed to the device nearing end of service.It was reported that the seizures were not an increase above the patient's pre-vns baseline frequency and that the physician wants to get the generator replaced to prevent the seizures from becoming worse.No known surgical interventions have been performed to date.

Event Description

The patient underwent generator replacement.The explanted generator has not been received for analysis to date.

Event Description

The explanting facility indicated that they no longer have the generator; therefore, product analysis cannot be performed.

• 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: 5311287
• MDR Text Key: 33894691
• Report Number: 1644487-2015-06795
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2015

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: 04/30/2013
• Device Model Number: 103
• Device Lot Number: 3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2016; 02/11/2016; 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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: 37 YR