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Model Number 102
Event Date 12/12/2006
Event Type  Injury  
Event Description

It was reported that the patient had her vns explanted on (b)(6) 2012 when it was originally believed that she would be getting a replacement surgery on that date. Follow up confirmed that a replacement system was not implanted. It was mentioned that the generator may have been at end of service and that the patient did not believe the device was helping her. Product analysis on the generator was completed on (b)(6) 2012. 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 and no anomalies were found. Product analysis on the lead was completed on (b)(4) 2012. The lead connector had detachment at the ring/backfill interface. Both the positive and the negative coil were retracted against the connector ring assembly and in contact inside the connector boot resulting in a short circuit condition. Based on the appearance of the lead, it is believed that this condition was most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. On (b)(6) 2012 a vns implanting surgeon reported that the patient came to him to get her vns removed because it had already been determined by her neurologists that the device was not working and she did not want to go to her previous surgeon. Per the surgeon, the patient also expressed that the device was giving her pain. It was reported that the patient began having pain at the site of the vns immediately after her initial surgery and that the pain radiated to her left hand as well. This occurred 24/7 and affected how the patient sat, moved, and performed day to day activities. The pain was described as a "shocking"; sensation involving the arm and the shoulder. The patient notes that she cannot hold a coffee cup or wash dishes because she has "charley horses"; of the neck along the course of the vns wire. The patient also stated that she cannot turn her neck because it feels "squeezed tight"; and her whole chest tightens up. Per the surgeon, the neurologist had turned off the vns three months prior, however despite the shocking component of the pain becoming less often; she still had a frequent pain. During the time the vns was working, the patient did not recall the pain occurring solely during stimulation time, and the seizures did not increase once the device was turned off. The surgeon was unsure if the patient's symptoms could be explained based on the vagus nerve stimulator. He indicated that there are no nerves that go from the area of the vagus nerve or the left subcutaneous anterior chest to the left hand, so he could not explain most of the patient's symptoms based on the presence of the device. In addition, the fact that the symptoms persisted even when the device was turned off was additional evidence that the patient's current symptoms were not caused by the device and that removal of the device would not make her symptoms go away. On the other hand, the patient was quite clear that her symptoms began immediately after implantation of the device, so the surgeon explained that it was possible that the surgery to implant the device could have triggered the onset of symptoms. Follow up was performed with the neurologist, however, they stated that he had not seen the patient since (b)(6) 2011 and had no information on the patient.

Manufacturer Narrative

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key2763658
Report Number1644487-2012-02421
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2007
Device MODEL Number102
Device LOT Number014865
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/11/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 09/27/2012 Patient Sequence Number: 1