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); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Clinic notes were received indicating that the vns patient was experiencing an increase in seizures in (b)(6) 2013.The patient¿s device settings were increased during an office visit on (b)(6) 2013 and the patient subsequently developed throat pain and voice hoarseness.The patient¿s device settings were adjusted on (b)(6) 2013.The patient did not have any seizures but continued to have painful stimulation.On (b)(6) 2013, the patient¿s device settings were increased and the patient reported no pain but persistent voice hoarseness.Follow-up revealed that diagnostic results at the time showed normal device function.The patient¿s seizures were above pre-vns baseline levels, but not all of the patient¿s seizures types increased.No changes occurred to the patient¿s medications or device settings which may have caused or contributed to the event.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• 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: 3941357
• MDR Text Key: 21968959
• Report Number: 1644487-2014-01813
• 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: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2010
• Device Model Number: 102
• Device Lot Number: 200816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR