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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Fever (1858); Headache (1880); Seizures (2063)

Event Date 06/06/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain.Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well.The patient¿s device settings were increased during the visit.The patient presented with increased chest pain during an office visit on (b)(6) 2014.A chest ct was reported by the physician to be unremarkable.The patient¿s device settings were lowered during the office visit.The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014.The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation.The patient reported that she was still feeling electricity-like pain in her arm and palm.The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013.It was confirmed that the events are occurring continuously as well as with stimulation.She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously.Additionally, she was seizure-free for a while and had one seizure.At that time, diagnostics were normal and the battery was reported to be fine as well.Attempts for additional relevant information were made but have been unsuccessful to date.

• 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: 3717363
• MDR Text Key: 4228801
• Report Number: 1644487-2014-00835
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2010
• Device Model Number: 102
• Device Lot Number: 2270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR