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

Model Number 103

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2013

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported that the current device was programmed to 3 ma output current, 1.8 minute off time, and 500 usec pulsewidth.The patient is implanted with a model 103 generator.Review of battery longevity tables show that if the device was programmed to the above output current and pulsewidth at a 33% duty cycle, the device would likely reach ifi status (from beginning of life) in 1.4 years.

Event Description

Additional information was received that the patient is scheduled for generator replacement on (b)(6) 2014.No information has been received indicating whether or not surgery was performed as scheduled.

Event Description

Additional information was received that the product analysis was completed on the generator.With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2.035 volts, indicating a neos condition.However, during a diagnostic test attempt, the battery voltage dropped less than 2.00 volts, which shows that the battery is depleted (eos) when the device attempts to enter a functional mode.The data in the diagaccumconsumed memory locations revealed that 93.431% of the battery had been consumed.The post burn-in electrical test results show that the pulse generator module performs according to functional specifications.Other than the noted events, there were no additional performance or any other type of adverse conditions found with the pulse generator.

Event Description

Additional information was received that the patient the patient had a generator replacement.The generator was returned to the manufacturer for evaluation.Product analysis is un process but has not been completed.

Manufacturer Narrative

Brand name , corrected data: previously submitted mdr indicated that this was unknown; however, the device appears to be a model 103 generator information.Model #, corrected data: previously submitted mdr indicated that the model was unknown; however, this should be 103.This report is being submitted to correct this information.If implanted, give date (mo/day/yr), corrected data: previously submitted mdr indicated that this was unknown; however, the device was originally implanted in 2012.This report is being submitted to correct this information.

Event Description

It was reported that the physician was planning on replacing the patient's generator because it's "indicating the need for replacement".The physician indicated that this seems odd.It was later reported that the generator showed ifi and surgery was cancelled.Attempts to obtain additional information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 3658664
• MDR Text Key: 4267015
• Report Number: 1644487-2014-00587
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 103
• Device Lot Number: 3045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• 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: 24 YR