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

Model Number 102R

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

Patient Problems Pain (1994); Seizures (2063)

Event Date 06/01/2012

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported that this vns patient experienced an increase in seizure frequency during (b)(6) 2012 for an unknown reason.The physician reported that the patient's seizures were cyclic in nature and increased despite vns therapy and without any triggering factor.The seizures resolved to a normal baseline; however, no other information regarding interventions or device functionality at the time was available.It was also reported that the patient experienced pain in the left neck at the electrode site that was reported to the physician on (b)(6) 2012.The pain was occurring with stimulation on times and corresponding with voice alterations.The physician told the patient to tape the magnet over the device; however, this did not cause the pain to stop.X-rays were taken at the patient's appointment on (b)(6) 2012; however, there was nothing remarkable, per the x-ray report.The pain spontaneously resolved at an unknown date.Based on the information available, the physician did not believe the event was related to vns.

• Brand Name: PULSE GEN MODEL 102R
• 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: 3575810
• MDR Text Key: 4142437
• Report Number: 1644487-2014-00233
• 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
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 102R
• Device Lot Number: 2480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2009
• 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: 36 YR