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

Model Number 103

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 09/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing increased painful stimulation at the generator site and an increase in seizures since (b)(6) 2014.The patient¿s vns generator was disabled due to pain and the patient was referred for surgery to explant the device.The patient¿s explant surgery was being planned for patient comfort.No known surgical interventions have occurred to date.Follow-up revealed that the patient¿s increase in seizures were worse with vns stimulation.The patient did not have any seizures while the device was disabled.The physician stated that the pain was due to the presence of the device.The patient¿s device was tested and showed normal device function.

Event Description

It was inadvertently reported in the initial mdr that no surgical interventions have occurred to date.The patient underwent explant of the vns device but the explant facility chose not to return the explanted generator.Therefore, product analysis of the explanted generator could not be performed.

Manufacturer Narrative

Event description, corrected date: it was inadvertently reported in the initial mdr that no surgical interventions have occurred to date.If explanted, give date (mo/day/yr), corrected data: 11/17/2014.The explant date was inadvertently left off from the initial mdr report.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4277380
• MDR Text Key: 5296498
• Report Number: 1644487-2014-03131
• 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,Followup
• Report Date: 10/30/2014

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: 08/31/2013
• Device Model Number: 103
• Device Lot Number: 3119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2011
• 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: 27 YR