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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 10/01/2011
Event Type  Malfunction  
Event Description

It was initially reported on (b)(6) 2012, that a patient presented high lead impedance on systems diagnostics (7/limit/high/no) during a routine office visit. The patient had some chest pain with stimulation that began a few weeks prior to the office visit. There were no reports of trauma or manipulation. The patient was no longer able to feel stimulation in her neck. The last acceptable diagnostics were (b)(6) 2011, on systems that resulted in ok/ok/2/no and ok/ok/4/no on normal mode. The patient's current settings are 2. 25/30/750/21/3/0/750/60. The patient began to experience an increase in depression since december however it is below baseline levels and the physician believes it is due to the high lead impedance. There were no recent changes in settings, medications, or lifestyle. X-rays were taken and sent to the manufacturer for review. No lead discontinuity was found however there was a portion of the lead is behind the generator and continuity in that portion of the lead cannot be assessed. Clinic notes were received dated (b)(6) 2012, where it was noted that the patient had gradually increasing depression from (b)(6) 2011. Adjustments to the patient's medications were being made at the same time so the patient was not alarmed however the patient began to notice her depression worsening with an increase in manic episodes with rushed thoughts and speech along with a mild spending spree. The patient also had one episode of self-mutilation were she cut her left forearm however there were no current thoughts of self-harm. The self-mutilation is part of the patient's depression as well as the mania. When the depression is worse, these events are more pronounced. The patient does have a history or mania as well as self-harm prior to being implanted with vns. The patient was referred to a surgeon for an appointment on (b)(6) 2012, for evaluation prior to lead replacement. It is unknown when/if revision surgery will occur at this time. In notes dated (b)(6) 2012, it stated that the patient had some mild discomfort in her left chest and no longer had pain in her throat with device stimulation. The chest pain was described as sharp and would increase whenever the physician's assistant pressed on the generator. The device was programmed off on (b)(6) 2012.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but cannot be confirmed as the device remains implanted in the patient and analysis is not possible at this time.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2536485
Report Number1644487-2012-00980
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 03/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1316
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/22/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/16/2012 Patient Sequence Number: 1
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