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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 302-30
Event Date 03/01/2007
Event Type  Malfunction  
Manufacturer Narrative

Device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Initial reporter indicated that their patient was having an increase in seizures. In the last 2. 5 months he has been having a lot of seizures. Not over his pre vns baseline and the doctor is attributing them to the patient's stress that he is having at the moment. As part of a retrospective complaint review associated with an investigation of how impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly replated to a short-circuit condition.

 
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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 Key1478431
Report Number1644487-2009-01407
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/08/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2004
Device MODEL Number302-30
Device LOT Number6182
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/08/2009
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/01/2002
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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