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

Model Number 103

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

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 06/24/2015

Event Type  Injury  

Event Description

It was reported that the vns patient¿s device was disabled for mri on (b)(6) 2015.After the mri, the physician attempted to interrogate the patient¿s device, but the patient reported experiencing erratic stimulation from her device when the programming wand was placed near the generator.The patient¿s device was interrogated and found still programmed off.The patient did not experience any erratic stimulation prior to device disablement.The physician programmed the patient¿s device back on to previous settings.The patient also reported having chocking sensations and pain and numbness in her left arm associated with stimulation on-times.It was noted that the patient was mentally delayed, but the physician stated that the patient¿s symptoms did not appear to be psychological.On (b)(6) 2015, the patient returned to the clinic and the patient¿s device magnet mode was disabled.The patient continued to experience erratic stimulation from her device.The patient went to the emergency room on (b)(6) 2015.The patient¿s device was disabled and the issues resolved.X-rays were taken and were reported by the physician to be unremarkable.The patient was evaluated by the surgeon on (b)(6) 2015.The patient¿s device was programmed on and tolerated the programming session well.The patient device was tested and showed normal device function.No further information relevant to the event has been received to date.

Manufacturer Narrative

Corrected data: the initial mfr.Report inadvertently reported the event as a malfunction rather than a serious injury.

• 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: 4940403
• MDR Text Key: 20127326
• Report Number: 1644487-2015-05335
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 103
• Device Lot Number: 202670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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: 28 YR