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Model Number 102
Event Date 08/26/2011
Event Type  Injury  
Event Description

Clinic notes regarding this vns patient were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient presented with a major complaint of frequent migraines. These were occurring so often that the patient became dehydrated and was hospitalized numerous times in the past year. The patient had to have iv fluids and narcotics in order to control them. The patient and her husband both felt that the patient was having more migraines since vns implant. The patient came in to request that the device was turned down or off to see if this may have some effect on her migraine frequency. The patient's headaches were now almost daily and severe two or three times a week. The patient was largely in the right side of her head and was associated with an inability to stand noise, light, movement, nausea, and vomiting. The patient was seeing a physician for the migraine treatment at least one per month (or every other month). It was also noted that the vns had not seemed to help the patient's seizures. The exact seizure frequency was not known but that patient averaged, at least, anywhere from two to five generalized tonic-clonic seizures per month and six complex partial seizures per month. The patient believed these were less now than before although the previous frequency estimate was somewhere between four and five per month. The patient's settings were altered at this appointment. The physician noted that the changes would be turning the device to less than therapeutic levels. The physician also seriously doubted that it would cause any migraines. It was noted that the patient's medications were all associated with increase seizures in patients predisposed; however, the patient had more of a problem with the pain from migraines. The patient's settings from (b)(6) 2011 were provided. It was also noted that patient wanted her vns turned down or off. The patient's migraines seemed worse with vns. Notes dated (b)(6) 2011 indicated that the patient's severe migraines were worse and more frequent and that the patient had been hospitalized with migraines with dehydration. The patient's seizure and headache frequencies were also noted. Notes dated (b)(6) 2010 also provided seizure and headache frequencies and stated that the migraines may last up to four days. The patient felt that the partial seizure frequency had decreased. Notes dated (b)(6) 2010 indicated the patient's seizure frequency, but the text was illegible. It was written that the patient felt that the partial seizure frequency decreased. The patient's migraines may last up to four days.

Event Description

On (b)(6) 2012, this patient's settings were adjusted to reach more efficacious levels. Diagnostics on this day were within normal limits. On (b)(6) 2012, the patient was reportedly having an increase in seizures, lack of efficacy, voice alteration, and an increase in depression. The patient reported potentially having the explanted due to the adverse events.

Event Description

Per the return product form, the device was explanted because the patient did not want it. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿pain with stimulation¿). The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. Based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Since a portion of the lead assembly (body) including the electrodes array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.

Event Description

(b)(4). Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Analysis of programming history.

Event Description

On (b)(6) 2012, it was reported that the patient's settings were changed. The patient's neurologist felt that the patient had pseudoseizures and anxiety. The patient was requesting explant. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Event Description

Clinic notes dated (b)(6) 2013 were received indicating that the patient was referred for removal of her vns. The patient had three grand mal seizures per month on average. The device was disabled in (b)(6) 2012. The patient was currently having one grand mal seizure and one partial complex seizure per week. The patient had significant a significant medical condition of depression. The patient also presented with headaches. The headaches occurred daily. Associated signs and symptoms included phonophobia, photophobia, and scalp soreness. The headaches were incapacitating. Stress, phonophobia, and photophobia were possible exacerbating factors. The patient is continues to have migraines which she takes morphine for. The physician would like to find a different non-opioid medication to control the patient¿s headaches. Per the physician morphine had the tendency to lower seizure threshold in some patient and can cause rebound headaches.

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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 Key2773585
Report Number1644487-2012-02521
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/06/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number102
Device LOT Number016488
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/04/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/08/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 10/05/2012 Patient Sequence Number: 1