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

Model Number 102

Device Problems Low Battery (2584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 04/28/2017

Event Type  Injury  

Event Description

Clinic notes indicated that a patient was experiencing an increase in nocturnal seizures.The physician later referred the patient for generator replacement surgery since the patient's device had been implanted for over seven years.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The patient underwent generator replacement surgery due to reported battery depletion.A company representative present at the surgery reported that the patient's explanted device was unable to be interrogated to due reaching end-of-service.The explanted generator was discarded after surgery and is unavailable for analysis.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6665798
• MDR Text Key: 78343678
• Report Number: 1644487-2017-04036
• 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
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2011
• Device Model Number: 102
• Device Lot Number: 2495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2009
• 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: 42 YR