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

Model Number 105

Device Problem Low Battery (2584)

Patient Problem No Code Available (3191)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

It was reported that the generator battery was showing low.The patient had recently undergone generator replacement on (b)(6) 2014.The physician's office indicated that the patient was last seen on (b)(6) 2015, but that there was no indication of low battery in the clinic notes.It was reported that electorcautery was not used during the generator replacement surgery and that following the surgery there was no evidence of low battery when diagnostics were performed.It is unknown whether or not the patient underwent a separate surgery since generator replacement that may have resulted in damage to the vns system.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description

Additional information was received that the patient's device was checked did not show any low battery indicator.It was reported that the neurologist confused this patient's battery status with that of a different patient he saw, with no evidence of pre-mature battery depletion being alleged.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4664405
• MDR Text Key: 17335921
• Report Number: 1644487-2015-04386
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 105
• Device Lot Number: 202868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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: 44 YR