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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 04/21/2009
Event Type  Malfunction  
Event Description

Clinic notes were received that reported a pt had high lead impedance, having a change in their seizure type and increased seizures around the time of the event. The pt underwent full revision surgery, and the explanted product is at the mfr pending completion of product analysis.

 
Manufacturer Narrative

Device malfunction suspected, but did not cause a death.

 
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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 Key1514166
Report Number1644487-2009-02352
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/24/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2006
Device MODEL Number302-20
Device LOT Number011190
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/07/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/24/2009
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2004
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: 10/21/2009 Patient Sequence Number: 1
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