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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 03/24/2009
Event Type  Malfunction  
Event Description

Reporter indicated a vns therapy patient underwent generator replacement surgery. During the surgery, the surgeon noted the lead was "all balled up" and off the nerve. The surgeon elected to explant the entire vns therapy system. At a later date, the patient underwent vns therapy implant surgery. The explanted products were returned to the manufacturer and are pending analysis. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1421314
Report Number1644487-2009-00849
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/23/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2002
Device MODEL Number300-20
Device LOT Number37128C
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/08/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/24/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2000
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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