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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 09/04/2009
Event Type  Injury  
Event Description

Reports indicated a vns therapy patient was admitted to the hospital for bradycardia and was in the ccu. The cardiologist feels that the patient's bradycardia may be related to his vns. Additional information received indicated the physician originally believed the vns may have had something to do with the bradycardia and wanted to turn it off but later decided the patient still needs a pacemaker. Good faith attempts to obtain additional information 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 Key1491034
Report Number1644487-2009-02231
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2002
Device MODEL Number101
Device LOT Number1353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/04/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2000
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: 10/02/2009 Patient Sequence Number: 1
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