MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Cognitive Changes (2551)

Event Date 03/05/2014

Event Type  Injury  

Event Description

In 2020, the patient's mother reported that prior to the patients' 2014 generator replacement the patient had increased seizures and a change in thought processing speed.Which she believed was due to a waning battery.It should be noted that the patient's generator was originally reported to be replaced prophylactically.The explanted generator was returned for analysis.The generator passed final functional and quality specifications prior to release.The generator battery status was at ifi-yes (intensive follow-up indicator) so the generator was still able to provide the intended amount of stimulation.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10949124
• MDR Text Key: 219865325
• Report Number: 1644487-2020-01619
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2020

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: 04/07/2012
• Device Model Number: 103
• Device Lot Number: 2703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2010
• 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: 21 YR