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Model Number 102
Event Date 11/19/2012
Event Type  Injury  
Event Description

Additional information was received which indicates that the physician who reported the tests from the microbiology lab were negative was mistaken. It was found that there were, in fact, no tests performed. It was stated that the patient's primary vns treating physician has the most accurate information on the patient, which indicates that the patient has been pain free since (b)(6) 2013 and all tests have been cancelled. No additional information has been provided.

Event Description

On (b)(6) 2013 it was reported by the physician that the patient may have an infection at the generator site. However, follow up with the neurologist found that there is not much evidence to support an infection and that a scan is being performed simply to rule out all possibilities of one. It was originally reported that the patient was feeling continuous stimulation and shocks in the neck at the electrode site. However, the neurologist stated that it is unknown what the cause of the pain is and if there is a relation to vns. The neurologist performed diagnostic tests on the device which showed that it was within normal limits and stated that no trauma or patient manipulation had taken place which could have caused or contributed to the event. No medical interventions were taken or planned at this time. X-rays of the patient were taken, but no abnormalities were noted. A review of the x-rays by the manufacturer found no obvious lead discontinuities in the areas that could be assessed. The generator was seen in the left chest area in a normal orientation and the filter feedthru wires appeared intact. The lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. Due to the image quality, it could not be assessed if the lead is intact at the connector pin. The lead was seen routed from the electrodes to the generator. A portion of the lead appeared to be behind the generator and could not be assessed. The electrodes were observed in the neck and appeared to be in proper alignment; however, the positive electrode appeared to be at a slightly different angle than the negative electrode. This could be due to the electrode beginning to come off or due to patient anatomy. No gross lead fractures or sharp bends were visualized. Follow up with the neurologist found that the patient felt the pain as a continuous sensation of electric shock over the left cervical thoracic region which persisted even when both the output current and magnet output current were set at 0ma. The device was turned off for 15 minutes to test if the pain continued without stimulation. The patient's settings were found to be output current = 1. 5ma, frequency = 30hz, pulsewidth = 500usec, on time = 30 sec, off time = 10 min, magnet current = 0ma, magnet on time = 30 sec, magnet pulsewidth = 500usec. Normal diagnostic results showed communication = ok, output current = ok, dcdc=2, eos = no. A system diagnostic test was not performed. An exploratory surgery is being considered to determine the cause; however, surgery has not been scheduled yet. Per the surgeon, if the exploratory surgery occurs it would be for patient comfort. No medical or surgical intervention has been planned or taken to preclude a serious injury. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Manufacturer Narrative

Name and address, corrected data: incorrect initial reporter listed in initial mdr inadvertantly.

Event Description

Follow up with a physician on (b)(6) 2012 found that the results from the microbiology lab were negative. It was stated that the patient still feels pain on her chest so the surgeon will probably remove the device. However, follow up with the primary treating physician found that the patient was no longer feeling pain as of (b)(6) 2013 and that all tests have been cancelled. The primary treating physician stated that he never suspected an infection and that this hypothesis was evoked by the surgeon on (b)(6) 2013 but never proven. It was stated that the source of these symptoms are still unknown. No additional information has been provided.

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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2975611
Report Number1644487-2013-00494
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2013
Device MODEL Number102
Device LOT Number201721
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/27/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/06/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 02/25/2013 Patient Sequence Number: 1