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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/01/2004
Event Type  Injury  
Event Description

Treating cardiologist reported that a vns patient was experiencing black out spells. The patient had her generator replaced for an unknown reason and is still experiencing the blackout spells. The physician reportedly believes the patient is having bradycardia due to vns therapy which is causing the patient to have the black out spells and then subsequently a seizure. Physician states that he plans on having the device programmed off to assess vns therapy relationship. Attempts for further information have been used to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1269757
Report Number1644487-2008-03019
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/18/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number102
Device LOT Number009157
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/18/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2003
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: 12/18/2008 Patient Sequence Number: 1
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