MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Battery Problem (2885); Communication or Transmission Problem (2896); Programming Issue (3014)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/15/2016

Event Type  malfunction  

Event Description

Information was received which indicated that the mother of a patient believed that the patient¿s generator was depleting faster than anticipated.Information received from the physician¿s office indicates that the battery was still green as of (b)(6) 2016.An internal battery life calculation was performed using settings available in the programming history database.The battery life calculation indicated that the patient had at least 10 years remaining until reaching near end of service using the settings provided by the physician.The accuracy of this result may vary depending on setting changes that were not captured in the programming history database and energy used during magnet swipes.No other information has been received to date.

Event Description

Additional programming and decoder data was reviewed.The information observed showed that the patient's generator showed that no battery flags were observed as of (b)(6) 2016.The information showed that the voltage of the patient's generator was at 3.037v and only 9.276% of the battery capacity was used as of (b)(6) 2016.

Event Description

Electrocautery precautions were followed by the surgeon in the patient's surgery on (b)(6) 2013 per the surgeon.Decoder information from (b)(6) 2013 was reviewed and showed that the voltage of the patient's generator was at 3.515v, which is above any battery status warnings.No other relevant information has been received to date.The explanted generator has not been received to date.

Event Description

Clinic notes for the patient's implant surgery and explant surgery were received.The notes from the implant surgery indicate that electrocautery was used during the initial implant surgery.The notes from the explant surgery indicate that the patient's generator could not be communicated with prior to the explant surgery and that the patient had an increase in seizures in addition to a reduction in intensity of perceived stimulation.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 6114779
• MDR Text Key: 60853804
• Report Number: 1644487-2016-02653
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2015
• Device Model Number: 105
• Device Lot Number: 202613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2017; 02/01/2017; 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2013
• 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: 28 YR