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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 01/01/2011
Event Type  Injury  
Event Description

It was initially reported in clinic notes that the patient had a right frontal subcortical ischemic stroke that lead to bilateral hematomas, unknown relationship to vns. The patient was also experiencing an increase in seizures, unknown cause or relationship to vns. It is unknown if the increase in seizures is above or below baseline. The patient had a cluster of three seizures on (b)(6) 2011 and it was taken to the emergency room. Blood work showed mild hyponatremia. The patient had a prophylactic generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2196462
Report Number1644487-2011-01773
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2001
Device MODEL Number101
Device LOT Number35713C
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/21/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2000
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: 08/03/2011 Patient Sequence Number: 1
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