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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 07/01/2009
Event Type  Injury  
Event Description

It was initially reported that the vns pt had surgery where the generator was replaced due to an unk reason. Further follow up with the physician revealed that the pt was experiencing a sudden onset of painful stimulation in the neck and disabled the device. The painful stimulation resolved, however, the pt subsequently had a 50% increase in seizure activity, and therefore, the physician referred the pt to a surgeon. There was no report of any pt trauma. There was also no causal or contributory programming changes, medication changes, or other eternal factors that preceded the onset of the painful stimulation. Device diagnostics provided by the physician, indicate normal device function. During surgery, the generator was replaced and the neck incision was opened to examine the lead strain relief. The surgeon excised some adhesions that had formed around the lead boy and the tie-downs used to secure the lead strain relief. The surgeon also "loosened" the lead strain relief. The pt has been seen for follow-up with the treating physician since surgeon occurred and the device has been programmed back to therapeutic levels and the pt is no longer experiencing painful stimulation.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1481597
Report Number1644487-2009-02082
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2004
Device MODEL Number302-20
Device LOT Number7083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/09/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2002
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: 09/22/2009 Patient Sequence Number: 1
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