MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem High impedance (1291)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing pain in her neck and chest during stimulation on-times and was constantly sore at areas around the lead.The patient¿s lead was found to be visible in the patient¿s neck where it previously was not visible.The patient¿s device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 3062 ohms).Patient trauma is not believed to have caused or contributed to the high impedance.The physician believed that the issues were related to an end of service condition with the patient¿s device.A battery life calculation using the available programming history showed approximately 7.4 years until near end of service.The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• 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: 4397157
• MDR Text Key: 5365327
• Report Number: 1644487-2015-03563
• 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
• Report Date: 12/10/2014

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: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2010
• 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: 41 YR