MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Difficult to Interrogate (1331); Operating System Version or Upgrade Problem (2997)

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

Event Date 11/19/2014

Event Type  malfunction  

Event Description

On 02/27/2015 it was reported that the physician¿s programming system is functioning properly.The patient did not show up to her appointment that day.The patient¿s rescheduled appointment date has been requested from the physician but no further information has been received.No additional information can be obtained until the patient is seen and her device is interrogated.

Event Description

The physician reported that he is unable to interrogate the patient¿s generator as the patient's generator is newer than his programming system will read.However, the physician's programming system should be able to interrogate the patient's generator.

• Brand Name: PULSE GEN MODEL 102R
• 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: 4501305
• MDR Text Key: 5572215
• Report Number: 1644487-2015-03793
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Model Number: 102R
• Device Lot Number: 201860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2011
• 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: 21 YR