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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

The pt's treating physician reported that when he tried to interrogate the pt's device, the settings had been reset. During the time, the device was off the pt went to the er following a generalized tonic colonic seizure, which is a new seizure type for the pt. The treating physician did not specify a cause for the new seizure type. Review of programming history confirmed that generator being disabled was due to a burst watchdog timeout. However, the reporter indicated a pt name that did not match the initials in the downloaded programming history. Attempts to clarify the pt- initials discrepancy with the physician have been unsuccessful to date.

 
Manufacturer Narrative

Analysis of programming history.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key1338733
Report Number1644487-2009-00436
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/05/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number103
Device LOT Number200590
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/05/2009 Patient Sequence Number: 1
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