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Event Date 04/10/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a patient's father reported that the patient's lead was extruding in the neck. No trauma or manipulation was reported. Earlier that day, the patient went to his primary care physician at which time the physician pulled the skin back over the site and sewed everything up. The patient's father provided images of the extrusion. Clinic notes were received on (b)(6), 2012 from two of the patient's appointments. (b)(6) 2012 notes reported that the patient had a generalized tonic-clonic seizure (gtcs) on (b)(6), 2012. The gtcs were usually triggered by lack of sleep. The seizure frequency was two per month. (b)(6), 2012 notes reported that the patient received a tingling sensation with stimulation and had about two general tonic-clonic seizures per week. On this occasion, the physician decreased the normal and magnet output currents and the normal pulsewidth. On (b)(6), 2012, the following information was received from the neurologist's office: no causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures or the lead body extrusion. The patient's medication was increased to handle the increase in seizures, but interventions for the lead extrusion were unknown as the patient was referred to a surgeon. The relationship of the increased seizures and lead extrusion to vns is unknown; however, the patient's pulsewidth and output current were decreased. The lead extrusion was first noted on (b)(6), 2012, and no patient manipulation or trauma was known to cause the lead extrusion. Diagnostic results were unknown, as was the pre-vns seizure frequency. No product information (model/serial number) was available. On (b)(6), 2012, information from the surgeon's was also received via phone. This information was also confirmed in clinic notes received on (b)(6), 2012 and dated (b)(6), 2012. It was reported that the patient experienced consistent swelling in the neck a few months prior. The patient was sent for excision of the pyogenic granuloma. No cultures were taken, but the patient was started on clindamycin. The area continues to drain blood and purulent material. At the time of the surgical procedure, the wires were exposed. Since that time, he has felt a shocking sensation in his arm and neck at times. Prior to vns, the patient was experiencing 7-10 grand mal seizures per day which has decreased to approximately one per month. The physician's assessment of the patient was a chronic neck infection after vns placement. The patient was scheduled for explant on (b)(6), 2012 with afb and fungal cultures to follow. It was recommended that the patient have at least two weeks of treatment prior to replacement. Attempts for the return of the explanted products will be made.

Event Description

On (b)(6), 2012, confirmation was received that the patient underwent surgery on (b)(6), 2012. On (b)(6) 2012, additional information was received that the patient had a full system put in and that the patient had been explanted due to an infection. It is unclear if the patient underwent explant on this date or at a previous surgery. Attempts for product return and additional information are underway.

Event Description

On (b)(6) 2012, follow up with the surgeon revealed that the patient's device was explanted on (b)(6) 2012 and reimplanted on (b)(6) 2012. Cultures were taken and returned positive for infection. The surgeon stated that a granuloma formed in reaction to the silicone tie-down at the lead site. The granuloma was removed, down to the wire. (the date of the granuloma removal was unavailable. ) the site continued to be infected. As a result, the patient's device was explanted. Attempts for product return and additional information have been unsuccessful. The hospital could not locate the explanted devices.

Manufacturer Narrative

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Type of DeviceLEAD
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 Key2585568
Report Number1644487-2012-01295
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/17/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 05/23/2012 Patient Sequence Number: 1