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

Model Number 103

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Code Available (3191)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that a patient's generator battery status was at near end of service in (b)(6)2015.However, the patient had his generator replaced on (b)(6) 2014.The physician was concerned that the battery was depleting more quickly than expected.Programming data was requested, but it has not been received to date.

Event Description

Programming data was received on 12/01/2015.The data was from 03/04/2014 to 10/06/2015.The first interrogation that was performed after surgery showed that the generator was pulse disabled (vbat < eos threshold).The battery voltage also depleted more quickly than compared to the battery life calculation that was performed.These pieces of information suggest that the device may have been in contact with an electrocautery device or static discharge during the implant procedure on (b)(6) 2014, which would have caused the battery to deplete much quicker than expected.These events are addressed in labeling.All diagnostic results were within normal limits.No known replacement surgery has occurred to date.

Event Description

The patient decided to have his vns explanted instead of having replacement surgery due to an unknown reason.Attempts for further information were unsuccessful to date.No surgery has occurred to date.

Event Description

The patient had generator replacement surgery on (b)(6) 2016 due to battery depletion.The explanted generator has not been received to date.

• 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: 5191318
• MDR Text Key: 30420149
• Report Number: 1644487-2015-06270
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 3398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2015; 02/15/2016; 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2012
• 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 Age: 23 YR