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

Model Number 102

Device Problem Low Battery (2584)

Patient Problem Seizures (2063)

Event Date 10/01/2016

Event Type  Injury  

Event Description

Clinic notes were received for patient's generator replacement referral.Per notes the patient is not feeling the vns as before.The device was interrogated and was observed to be dying due to end of service.Notes also indicate that the patient has been experiencing overall increase in seizures compared to few months ago (1 seizure per month vs currently 4 seizures per week).The increase in seizures was reported to be from (b)(6) 2016.Per mother, vns helped initially but medications were more helpful in controlling seizures.Patient has less frequent seizures since the vimpat was started but overall he is having more frequent seizures compared to a few months ago when he was to have one seizure a month.Patient underwent generator replacement.The explant facility does not return devices and discards them.

• 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: 6639053
• MDR Text Key: 77497376
• Report Number: 1644487-2017-03970
• 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
• Report Date: 06/13/2017

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: 05/21/2014
• Device Model Number: 102
• Device Lot Number: 3359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2012
• 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: 26 YR