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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  Malfunction  
Event Description

Reporter indicated that during a generator replacement surgery, it was noted that portions of the patient's neck appeared to be stimulated. Examination of the lead by the surgeon found that there was a bubble, and abrasion in the lead insulation. The surgeon suspected that the issue the patient was experiencing was likely due to current being leaked to the tissues surrounding the vagus nerve, instead of only the vagus nerve. The surgeon proceeded to replace both the generator and the lead. Attempts to have the explanted lead returned for analysis were unsuccessful as the product was discarded.

 
Manufacturer Narrative

Device failure suspected.

 
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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 Key1551281
Report Number1644487-2009-02665
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/26/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/25/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2005
Device MODEL Number302-20
Device LOT Number7469
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/26/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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