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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/11/2012

Event Type  Injury  

Event Description

It was reported by the vns treating physician that the patient¿s device was turned off on (b)(6) 2012 to prep for mri and not due to the pain.However, it was reported to be left off to preclude a potential serious injury.On (b)(6) 2012, the patient reported throat discomfort during stimulation on-times.The patient then reported on (b)(6) 2012, some chronic mild throat pain in the contact of allergies with congestion and sneezing (not related to vns).The vns device was turned off in preparation for mri, not to manage throat pain.It was reported that the patient was experiencing "stabbing" pain in anterior throat during stimulation on-times following increase vns to 1.50ma on (b)(6) 2011.The patient requested adjustment after two weeks.On (b)(6) 2011, the physician decreased settings for patient comfort (1.0ma).On (b)(6) 2012, the physician further decreased output current to manage the pain.

• Brand Name: PULSE GEN MODEL 102
• 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: 4694469
• MDR Text Key: 5652289
• Report Number: 1644487-2015-04457
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2010
• Device Model Number: 102
• Device Lot Number: 2151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2008
• 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: 62 YR