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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 03/01/2010
Event Type  Malfunction  
Event Description

It was initially reported to the mfr that the pt was admitted to the er because, the pt was experiencing neck swelling, painful stimulation and dyspnea. The pt was referred to a surgeon and was scheduled for a lead revision surgery due to a suspected lead break. The pt's treating neurologist believes the swelling and dyspnea are related to vns, dyspnea occurs with stimulation and the pt does not have any history of dyspnea pre-vns. The pt's lead body was replaced due to a lead break. It was indicated that there were no casual or contributing factors, or any pt manipulation or trauma that occurred to have contributed to the lead break. Good faith attempts to obtain more info regarding the suspected lead discontinuity have been unsuccessful to date. The explanted lead body has been returned to the mfr and analysis is in process.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to 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 Key1675414
Report Number1644487-2010-00982
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number302-20
Device LOT Number200203
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/21/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/25/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2006
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: 04/23/2010 Patient Sequence Number: 1
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