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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 11/10/2009
Event Type  Injury  
Event Description

It was reported that a vns pt was at risk of having his vns lead protruding due to lack of slack on the implanted lead, as the pt's body is growing. A neurosurgeon evaluated the pt and stated that the strain relief loop in the neck is being pulled as the pt grows. The surgeon plans to have the battery replaced soon, and would like to avoid changing the lead as the device is within normal limits (no specifics given). Additional info was received from the surgeon's office indicating the lead is not protruding, and the surgeon believes the event of lead pulling is related to the pt's normal growth. Further info was received through clinic notes dated 2009 indicating the pt was experiencing pain on the left side of the neck, and indicated the pt will pick at the lead and would project through the skin superficially. Another clinic note from three months later, indicated that at the moment there were no plans to replace the pt's lead, but exploratory surgery was scheduled in which the generator would be replaced prophylactically as the pt's mother wants the generator replaced.

 
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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 Key1549477
Report Number1644487-2009-02569
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/10/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2006
Device MODEL Number302-20
Device LOT Number11537
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/10/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2005
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: 12/01/2009 Patient Sequence Number: 1
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