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

Model Number 103

Device Problem Loss of Power (1475)

Patient Problem Seizures (2063)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient's vns battery is "shutting down".Additional information was received that the patient's battery was seen to be low (about 10%).Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free.These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards.Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation.No additional relevant information has been obtained to date.

Event Description

An implant card was received indicating that the patient underwent prophylactic generator replacement.It was reported that the explanted generator was discarded by the explanting facility.

• 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: 5339671
• MDR Text Key: 34913456
• Report Number: 1644487-2016-06874
• 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
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: 103
• Device Lot Number: 201567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2010
• 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): Other
• Patient Age: 28 YR