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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 01/01/2009
Event Type  Malfunction  
Event Description

Reporter indicated that the pt was in the hosp due to a fluid build-up around his generator. The pt had both the generator and lead removed. During the procedure, what appeared to be pus was found inside of the lead, and the negative electrode had "disintegrated" as per the company representative's account. During the procedure, cultures of the site were taken and were negative for an infection, but the surgeon still believed that the fluid build-up could be due to an infection that started during the pt's previous prophylactic generator replacement surgery, as the pt had been on multiple antibiotics since the beginning of the hospitalization. During the removal procedure, it was noted that there were metallic bits within the fluid that was surrounding the generator. Attempts for more info were unsuccessful. The lead has been returned to the manufacturer, along with the metallic bits found in the fluid surrounding the generator, for analysis, but analysis has not yet been completed.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization of both the generator and lead prior to distribution. Device failure suspected.

 
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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 Key1426599
Report Number1644487-2009-00731
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2003
Device MODEL Number300-20
Device LOT Number2836
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/13/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/09/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2001
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: 04/08/2009 Patient Sequence Number: 1
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