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Model Number 102
Event Date 03/01/2012
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2013, indicate the patient has pain in the left neck at the vns region. The patient feels the device is turning on when she touches it and thinks the lead in her neck is touching a muscle, thereby hurting her and sending pain into the ear, sensitivity in gums on jaw, and pain in shoulder and neck muscles. Per the notes, the vns "dysfunctioned" due to high output now with pain and with positional changes. The vns output current was disabled to 0 ma. Follow up was performed to confirm if a device malfunction is suspected; however, no clear answer was provided. The patient will be seen again to determine if a revision or explant surgery should be performed. Surgery has not occurred to date. The patient has reported several instances of pain since (b)(6) 2012; however, no interventions were taken or planned to preclude a serious injury at the time and device malfunction had not been alleged. Below is a summary of the previous allegations made concerning this patient: it was reported on (b)(6) 2012 that a patient could only feel stimulation if her head was turned to the left, and therefore, the patient believes it only works when her head is turned in that direction. The manufacturer¿s representative was present at the appointment and reported that the patient was demanding a full revision. The manufacturer¿s representative performed normal mode and system diagnostics with the patient in multiple positions, and the dcdc value was consistently 4 and 2, respectively. The patient¿s settings on this visit were 2. 5 ma, 25 hz, 250 microseconds, 21 seconds on, 0. 3 minutes off with magnet settings of 2. 75 ma, 250 microseconds, 60 seconds on. The patient reported that the erratic stimulation feeling first began in march when the output current was increased. No recent trauma or accidents were reported. Additional information was received on (b)(6) 2012 from the patient indicating that she awoke that morning with pain around the generator and described it as ¿feeling like a tearing sensation. ¿ the patient reported that she ¿started checking it out¿ and it hurt when she pushed on ¿certain areas. ¿ she also reported that the magnet stimulation did not feel as strong. Later on (b)(6) 2012, the patient reported to the manufacturer¿s representative that the magnet appeared weak. By turning the head to the left, the magnet feels weaker than before. The patient reported that she ¿just had a medium aura,¿ however there was no indication that this was an increase in auras or unusual for the patient. The manufacturer¿s representative attended the patient¿s appointment on (b)(6) 2012. The patient presented with her husband, and she reported that "she woke up one morning and had all this pain at the generator site when she pushed on the generator. " it was clarified that the patient slept on her left side that night on the couch, and she only had such pain the day after she slept on her left side with her left arm up. In addition, she admitted that the pain was due to her pushing on the generator. The patient is reportedly doing really well, and she hasn't had many seizures at all. She complained of voice alterations at the appointment, but the physician indicated that the patient was making her voice change on her own and it did not coincide with stimulation. The patient said it happened with magnet mode stimulation. The patient did seem to have a "jolt" of voice alteration about 60 seconds after she swiped the magnet which did not coincide with her swipe and settings. Diagnostics are fine, and everything is reportedly okay. The physician believes that the patient wants attention, and so she is asking for a full revision. However, she was not referred for surgery at this time. The physician said that he would refer her for surgery if she wants it though, because he likes to please his patients and this patient is persistent. No issues are suspected with the magnet strength, and no follow up was provided on the patient¿s auras. No issues were suspected by the physician. Additional information was received from the patient indicating that she was experiencing pain at the electrode site all day. The patient puts oil on it to alleviate the pain. The patient indicated that if she presses on the lead wire, it hurts even more, and the pain travels into the lower part of the left jaw. The more she turned her head or uses the magnet, the more the site hurts. Additionally, she indicated that she could not turn her head to the left to ¿get the strongest results¿ during vns stimulation and noted swelling in the neck. The patient has reportedly noticed the last couple of days that when she was icing her shoulder (believed to be unrelated) with the ice pack also touching her neck that the swelling had mostly gone down at the electrode site. Follow up with the tc for clarification revealed that the pain at the vns device site is related to operational context as she pushed on the device. The reported events are related to her mental conditions. Her seizures are not above pre-vns seizure frequency. No additional information could be provided as the patient has not been evaluated by the physician. Furthermore, the patient reported in (b)(6) 2013 that she felt the lead had migrated. Follow up with the md revealed that he does not believe lead has moved. Additionally, the ae¿s events that the patient previously reported have all resolved through device setting changes (not to preclude a serious injury). Diagnostics were reported to be within normal limits. The physician started dropping the output current and on time and it is not bothering her as much. The erratic stimulation has since resolved. Additional information was received from the patient on (b)(6) 2013 reporting that for about six months she has been feeling ¿some poking¿ in the electrode area with it hurting at times. During the prior six weeks when the patient went without a seizure, her neck ¿dramatically loosened up. ¿ after using the magnet, her neck tightened up again with pain on the left side of the neck. She has been lifting her head up when lying down to stretch the muscle and loosen up the neck for about the last two months. The patient also indicated that she was still having a problem with the strength feeling stronger when her neck is turned to the left. No additional information has been provided.

Event Description

The patient had a follow up visit on (b)(6) 2013 and it was decided that the vns device would be turned off for about two months to analyze if there was any change in seizures. If the seizures worsen, revision surgery would be considered. No surgery has been performed to date.

Event Description

The patient reported that she believes there may be an issue with her vns, because she was seizure free for eight years and is no longer seizure free. The patient is going to a pain management doctor and specialist for a nerve block, so there is no revision planned at this time.

Event Description

Additional information was received indicating that the vns patient¿s device was found to be programmed on during an office visit on (b)(6) 2014. At these settings, the patient was not able to perceive stimulation.

Manufacturer Narrative

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3312781
Report Number1644487-2013-02542
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2010
Device MODEL Number102
Device LOT Number201039
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/09/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/16/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial