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Model Number 102
Event Date 11/07/2009
Event Type  Malfunction  
Event Description

The patient reported on (b)(6) 2013 that he felt his vns device was ¿not working right¿ because he was feeling his stimulation since a couple of days prior which he had never experienced before. He started to feel his device turn on and can feel it pulsating in his neck where his scar is which had never happened previously. He reported that the treating neurologist did increase the vns settings a few weeks ago, but he did not notice any problems then. He reported that he believed everything was fine at his last visit. The patient denied any trauma or event that would have initiated the symptoms. Later, the vns company representative attended the patient¿s follow-up appointment on (b)(6) 2013 with a treating vns physician to assess the patient¿s symptoms and check the vns device. The patient reported about six months prior, the patient started feeling pain with stimulation by his clavicle and that about a month ago, the painful stimulation got more intense and he described it as a ¿spreading pain¿ which began in the clavicle area. The patient also started experiencing intense voice alteration with stimulation and was not able to talk when the device was stimulating. Upon performing diagnostics on the patient¿s device on (b)(6) 2013, high lead impedance was obtained with impedance value greater than 10,000 ohms. Therefore, the patient¿s device was disabled on this date, per manufacturer labeling recommendations. Clinic notes from (b)(6) 2013 reported that the patient¿s output current was increased on (b)(6) 2013 from 2. 25ma to 2. 5ma. The patient continued to complain of a ¿vibrating sensation in the left cervical region which would be consistent with the area of the lead. ¿ the physician notes that ¿it appears the patient¿s lead is faulty and therefore the device is being turned off. ¿ the patient was referred for replacement surgery. However, the surgery has not occurred to date. The cervical spine and pa/lateral views of the chest x-ray report dated (b)(6) 2013 reported no anomalies regarding the vns device. Attempts for a copy of the x-rays and additional information have been unsuccessful to date.

Event Description

Product analysis was performed on the returned generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. A bench lead inserted past the connector blocks. In addition, the in-line cavity go gauge test passed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the product analysis lab, 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.

Manufacturer Narrative

Review of device history records. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2013 it was reported that the patient¿s surgery ended up just a battery replacement. The surgical team could visually inspect that the lead pin was not fully inserted and full of fluid. When the pin was dried off and reinserted, the system diagnostics showed results within normal limits. On (b)(6) 2013 further details were received when it was reported that the patient¿s revision surgery was underway when the surgeons noted the pin on the generator was not fully inserted. The pin was cleaned and reinserted and the surgeons noted the pin came loose very easily when unscrewing the set screw. After pin reinsertion, the device was within normal limits with no high impedance observed. The surgeons, by referral from the neurologist, went forth with a prophylactic generator replacement. Again, diagnostics showed all systems within normal limits. The surgeons elected to not move forward with a lead revision at this point. The explanted generator was returned for product analysis on july 29, 2013. Product analysis is underway and has not yet been completed.

Manufacturer Narrative

Additional information was received which changes the product the report is reported on.

Manufacturer Narrative

Date of event; corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

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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 Key3199351
Report Number1644487-2013-01994
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/10/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number102
Device LOT Number201083
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/22/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial